Label: ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER- cattle hair and dander injection, solution
ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP- animal allergens, dog dander canis spp injection, solution
ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.- dog hair canis spp. injection, solution
ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER- ap horse hair .......ction, solution
POLLENS - TREES, MULBERRY MIX- mulberry mix injection, solution
POLLENS - TREES, OAK MIX- oak mix injection, solution
POLLENS - TREES, OAK, RED QUERCUS RUBRA- oak, red quercus rubra injection, solution
ANIMAL ALLERGENS, UF DOG HAIR-DANDER CANIS SPP- animal allergens, dog dander canis spp injection, solution
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NDC Code(s):
65044-0854-2,
65044-0854-3,
65044-0854-4,
65044-0856-2, view more65044-0856-3, 65044-0856-4, 65044-0879-4, 65044-1006-2, 65044-1006-3, 65044-1006-4, 65044-1018-2, 65044-1018-3, 65044-1018-4, 65044-1021-2, 65044-1021-3, 65044-1021-4, 65044-1060-2, 65044-1060-3, 65044-1060-4, 65044-1081-2, 65044-1081-3, 65044-1081-4, 65044-1084-2, 65044-1084-3, 65044-1084-4, 65044-1120-2, 65044-1120-3, 65044-1120-4, 65044-1168-2, 65044-1168-3, 65044-1168-4, 65044-1171-2, 65044-1171-3, 65044-1171-4, 65044-1172-2, 65044-1172-3, 65044-1172-4, 65044-1207-2, 65044-1207-3, 65044-1207-4, 65044-1213-2, 65044-1213-3, 65044-1213-4, 65044-1216-2, 65044-1216-3, 65044-1216-4, 65044-1217-2, 65044-1217-3, 65044-1217-4, 65044-1237-2, 65044-1237-3, 65044-1237-4, 65044-1297-2, 65044-1297-3, 65044-1297-4, 65044-1300-2, 65044-1300-3, 65044-1300-4, 65044-1303-2, 65044-1303-3, 65044-1303-4, 65044-1336-2, 65044-1336-3, 65044-1336-4, 65044-1339-2, 65044-1339-3, 65044-1339-4, 65044-1342-2, 65044-1342-3, 65044-1342-4, 65044-1343-2, 65044-1343-3, 65044-1343-4, 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65044-2487-2, 65044-2487-3, 65044-2487-4, 65044-2506-2, 65044-2506-3, 65044-2506-4, 65044-2508-2, 65044-2508-3, 65044-2508-4, 65044-2563-2, 65044-2563-3, 65044-2563-4, 65044-2599-2, 65044-2599-3, 65044-2599-4, 65044-2619-2, 65044-2619-3, 65044-2619-4, 65044-2622-2, 65044-2622-3, 65044-2622-4, 65044-2623-2, 65044-2623-3, 65044-2623-4, 65044-2624-2, 65044-2624-3, 65044-2624-4, 65044-2626-2, 65044-2626-3, 65044-2626-4, 65044-2629-2, 65044-2629-3, 65044-2629-4, 65044-2632-2, 65044-2632-3, 65044-2632-4, 65044-2633-2, 65044-2633-3, 65044-2633-4, 65044-2634-2, 65044-2634-3, 65044-2634-4, 65044-2635-2, 65044-2635-3, 65044-2635-4, 65044-2677-2, 65044-2677-3, 65044-2677-4, 65044-2854-2, 65044-2854-3, 65044-2854-4, 65044-2855-2, 65044-2855-3, 65044-2855-4, 65044-2856-2, 65044-2856-3, 65044-2856-4, 65044-2861-2, 65044-2861-3, 65044-2861-4, 65044-2862-2, 65044-2862-3, 65044-2862-4, 65044-2863-2, 65044-2863-3, 65044-2863-4, 65044-3014-2, 65044-3020-2, 65044-3041-2, 65044-3074-2, 65044-3077-2, 65044-3107-2, 65044-3116-2, 65044-3125-2, 65044-3134-2, 65044-3140-2, 65044-3173-2, 65044-3191-2, 65044-3203-2, 65044-3212-2, 65044-3215-2, 65044-3248-2, 65044-3254-2, 65044-3305-2, 65044-3362-2, 65044-3380-2, 65044-3389-2, 65044-3428-2, 65044-3449-2, 65044-3452-2, 65044-3455-2, 65044-3461-2, 65044-3509-2, 65044-3518-2, 65044-3548-2, 65044-3554-2, 65044-3565-2, 65044-3584-2, 65044-3596-2, 65044-3626-2, 65044-3656-2, 65044-3674-2, 65044-3695-2, 65044-3713-2, 65044-3716-2, 65044-4083-2, 65044-4083-3, 65044-4083-4, 65044-4085-2, 65044-4085-3, 65044-4085-4, 65044-4349-2, 65044-4349-3, 65044-4349-4, 65044-4352-2, 65044-4352-3, 65044-4352-4, 65044-4401-2, 65044-4811-2, 65044-4811-3, 65044-4811-4, 65044-4824-2, 65044-4824-3, 65044-4824-4, 65044-4850-2, 65044-4850-4, 65044-4855-2, 65044-4855-3, 65044-4855-4, 65044-5000-2, 65044-5000-3, 65044-5000-4, 65044-5004-2, 65044-5004-3, 65044-5004-4, 65044-5008-2, 65044-5008-3, 65044-5008-4, 65044-5020-2, 65044-5020-3, 65044-5020-4, 65044-5032-2, 65044-5032-3, 65044-5032-4, 65044-5048-2, 65044-5048-3, 65044-5048-4, 65044-5052-1, 65044-5052-3, 65044-5052-4, 65044-5055-1, 65044-5055-3, 65044-5055-4, 65044-5056-2, 65044-5056-3, 65044-5056-4, 65044-5076-2, 65044-5076-3, 65044-5076-4, 65044-5100-2, 65044-5100-3, 65044-5100-4, 65044-5104-2, 65044-5104-3, 65044-5104-4, 65044-5112-2, 65044-5112-3, 65044-5112-4, 65044-5124-2, 65044-5124-3, 65044-5124-4, 65044-5128-2, 65044-5128-3, 65044-5128-4, 65044-5136-2, 65044-5136-3, 65044-5136-4, 65044-5144-2, 65044-5144-3, 65044-5144-4, 65044-5168-2, 65044-5168-3, 65044-5168-4, 65044-5208-2, 65044-5208-3, 65044-5208-4, 65044-5220-2, 65044-5220-3, 65044-5220-4, 65044-5230-2, 65044-5230-3, 65044-5230-4, 65044-5235-2, 65044-5235-3, 65044-5235-4, 65044-5264-2, 65044-5264-3, 65044-5264-4, 65044-5284-2, 65044-5284-3, 65044-5284-4, 65044-6513-2, 65044-6517-2, 65044-6517-3, 65044-6517-4, 65044-6518-2, 65044-6518-3, 65044-6518-4, 65044-6580-2, 65044-6580-3, 65044-6580-4, 65044-6581-2, 65044-6581-3, 65044-6581-4, 65044-6584-2, 65044-6584-3, 65044-6584-4, 65044-6587-2, 65044-6587-3, 65044-6587-4, 65044-6588-2, 65044-6588-3, 65044-6588-4, 65044-6589-2, 65044-6589-3, 65044-6589-4, 65044-6590-2, 65044-6590-3, 65044-6590-4
- Packager: Jubilant HollisterStier LLC
- Category: NON-STANDARDIZED ALLERGENIC LABEL
Drug Label Information
Updated November 5, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NON‑STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS AND INSECTS) safely and effectively. See full prescribing information for NON-STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS AND INSECTS).
NON-STANDARDIZED ALLERGENIC EXTRACTS (POLLENS, MOLDS, EPIDERMALS AND INSECTS)
Solution for percutaneous, intradermal, or subcutaneous administration Initial U.S. Approval: 1925WARNING: ANAPHYLAXIS
See full prescribing information for complete boxed warning.
- Non-standardized allergenic extracts can cause anaphylaxis, including anaphylactic shock and death.(5.1)
- Do not administer to individuals with severe, unstable or uncontrolled asthma, history of severe systemic reaction to the allergen extract when administered for diagnosis or treatment, or with medical conditions that reduce the ability to survive anaphylaxis.(4)
- Observe individuals for at least 30 minutes following administration.Emergency measures and personnel trained in their use must be available in the event of a life-threatening reaction.(5.1)
- Individuals with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, or exposed to similar allergens may be at increased risk of anaphylaxis.(5.1)
- These products may not be suitable for individuals who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.(5.1)
INDICATIONS AND USAGE
Non-standardized allergenic extracts are indicated for:
DOSAGE AND ADMINISTRATION
For percutaneous, intradermal, or subcutaneous use only.
Administration:
- Percutaneous for diagnostic testing.
- Intradermal for diagnostic testing.
- Subcutaneous for immunotherapy.
See full prescribing information for details on dosing and dilution preparation. (2)
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
The risk of anaphylaxis may be increased in the following situations:
- Extreme sensitivity to non-standardized allergenic extracts.
- Concomitant environmental exposure to similar allergens.
- Receipt of high concentrations and volumes of non-standardized allergenic extracts.
- Receipt of an accelerated build-up schedule (e.g., "rush" immunotherapy).
- Changing to another lot of allergen.(5)
ADVERSE REACTIONS
Common adverse reactions reported for non-standardized allergenic extracts are:
- Local adverse reactions, occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy (e.g., erythema, swelling, pruritus, tenderness and pain at the injection site).(6)
- Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy (e.g., generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension).Systemic reactions may be fatal.(6)
To report SUSPECTED ADVERSE REACTIONS, contact Jubilant HollisterStier at 1-800-495-7437 or Adverse.Reactions@jhs.jubl.com; or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
- Certain medications may decrease skin test wheal and erythema responses, including antihistamines, topical corticosteroids, topical anesthetics, and tricyclic antidepressants.(7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 10/2024
-
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ANAPHYLAXIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Diagnostic Testing
2.3 Immunotherapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis
5.2 Cross-reactions and Dose Sensitivity
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Antihistamines
7.2 Topical Corticosteroids and Topical Anesthetics
7.3 Tricyclic Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
-
BOXED WARNING
(What is this?)
WARNING: ANAPHYLAXIS
- Non-standardized allergenic extracts can cause anaphylaxis, including anaphylactic shock and death.(5.1)
- Do not administer to individuals with:
- severe, unstable or uncontrolled asthma;
- history of severe systemic reaction to the allergen extract when administered for diagnosis of treatment;
- medical conditions that reduce the ability to survive anaphylaxis.(4)
- Observe individuals for at least 30 minutes following administration. Emergency measures and personnel trained in their use must be available in the event of a life-threatening reaction.(5.1)
- Individuals with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, or exposed to similar allergens may be at increased risk of anaphylaxis.(5.1)
- These products may not be suitable for individuals who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.(5.1)
-
1 INDICATIONS AND USAGE
NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for:
- Skin test diagnosis of individuals with a clinical history of allergy to the specific corresponding allergens.
NON-STANDARDIZED ALLERGENIC EXTRACTS are indicated for:
- Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for allergen specific IgE antibodies for the specific corresponding allergens.
-
2 DOSAGE AND ADMINISTRATION
For percutaneous, intradermal, or subcutaneous administration only. Do not inject intravenously.
2.1 Preparation for Administration
Appearance is clear to slightly opalescent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if either of these conditions exist.
Non-standardized allergenic extracts diluted with Albumin Saline with Phenol (0.4%) (stabilized diluent) may be more potent than extracts diluted with diluents that do not contain albumin. When switching from non-stabilized to stabilized diluent, consider less concentrated initial dilutions for both intradermal testing and immunotherapy.
Different formulations, preparations, or new lots of non-standardized allergenic extracts are not interchangeable. Dosing should be adjusted appropriately when formulations, preparations, or lots of non-standardized allergenic extracts are changed [see Immunotherapy (2.3) and Dosage Forms and Strengths (3)].
Allergenic extracts may be prepared for intradermal (diagnosis) or subcutaneous (immunotherapy) administration by diluting stock concentrates.
- For diluent, use sterile albumin saline with phenol or sterile normal saline with phenol.
- Dilute stock concentrates by a minimum of 100-fold for intradermal testing. Dilutions of 1,000-fold or greater are appropriate starting points for patients with a clinical history of adverse reaction.
To prepare dilutions for intradermal testing and immunotherapy, start with a stock concentrate, and prepare a ten-fold (1:10) dilution by adding 0.5 mL of concentrate to 4.5 mL of sterile aqueous diluent. Prepare subsequent dilutions in a similar manner. (see Table 1).
Table 1: 10-fold Dilution Series
Dilution
Extract
Milliliters of Diluent
Dilution Strength (w/v)
Dilution Strength (w/v)
Dilution Strength (w/v)
Dilution Strength (w/v)
Dilution Strength (w/v)
0
Concentrate
1:10
1:20
1:50
1:100
1:650
1
0.5 mL Concentrate
4.5
1:100
1:200
1:500
1:1,000
1:6,500
2
0.5 mL Dilution
4.5
1:1,000
1:2,000
1:5,000
1:10,000
1:65,000
3
0.5 mL Dilution 2
4.5
1:10,000
1:20,000
1:50,000
1:100,000
1:650,000
4
0.5 mL Dilution 3
4.5
1:100,000
1:200,000
1:500,000
1:1,000,000
1:6,500,000
5
0.5 mL Dilution 4
4.5
1:1,000,000
1:2,000,000
1:5,000,000
1:10,000,000
1:65,000,000
6
0.5 mL Dilution 5
4.5
1:10,000,000
1:20,000,000
1:50,000,000
1:100,000,000
1:650,000,000
Note: A lower starting dose and/or less concentrated dilutions may be necessary for highly sensitive patients with a clinical history of sensitivity, or for those who display severe symptoms. [see Diagnostic Testing (2.2),Percutaneous Skin Testing (2.2.1) and Intradermal (Intracutaneous) Skin Test (2.2.2)].
2.2 Diagnostic Testing
Testing is performed to identify patients that exhibit an allergic response at the site of administration. False positive reactions may occur. A positive skin test reaction must be interpreted in the context of the individual’s clinical history and known exposure to the allergen.
- Administer percutaneous tests prior to administration of intradermal tests to identify highly sensitive patients.
- Do not use allergen mixes for diagnostic testing because a positive reaction would not permit specific identification of the allergen(s) that elicited the reaction. In addition, a negative reaction would fail to indicate whether an individual component allergen would have elicited a positive reaction at full strength.
2.2.1 Percutaneous Skin Testing
Dose
Unless an individual is suspected to be at greater risk for anaphylaxis, the initial starting dose is 1 drop (approximately 0.05 mL) of undiluted allergenic extract. For individuals suspected to be at greater risk for anaphylaxis (for example, as indicated by a history of allergen-induced anaphylaxis), initiate percutaneous testing with a sequence of serial 10-fold dilutions of undiluted allergenic extract spaced 15‑20 minutes apart [see Preparation for Administration (2.1)].
Administration
- Percutaneous Test: Place one drop (approximately 0.05 mL) of allergen on the skin and pierce through drop superficially into the skin, lifting slightly. Use a skin test device, such as a sterile needle, lancet, or bifurcated needle.
- Percutaneous Test using self-loading devices: Refer to the manufacturer’s product instructions.
Concurrently, use a positive histamine skin test control to identify patients whose recent use of drugs with antihistamine activity may result in a false negative skin test. Apply a 50% glycerin solution as a negative control, to identify false positive responses to the extracting fluid used in the manufacture of allergenic extracts, or due to dermographism [see Drug Interactions (7)].
Interpreting Results
For interpretation of percutaneous skin tests, refer to the information provided in Allergy Diagnostic Testing: An Updated Practice Parameter.1 In addition, follow the directions provided with the percutaneous skin test devices. Measure wheal responses for the histamine positive control test at 15 minutes and for the allergen tests at 15 to 20 minutes.
- The negative control (50% glycerin solution) response should measure < 3 mm wheal and ≤ 10 mm flare.1
- Response to positive controls should be at least 3 millimeters larger than the response to the negative control.
- If either the response to the histamine positive control or to the negative control do not meet the criteria above for acceptable wheal size, the results for the allergenic extracts tested at the same time should be considered invalid and be repeated.
- Fire Ant: Percutaneous testing is considered positive when the response occurs at a concentration of 1:100 w/v or less.4
2.2.2 Intradermal (Intracutaneous) Skin Test
Always perform percutaneous tests prior to intradermal skin tests.1, 2
Dose
Perform intradermal tests with at least 100-fold less concentrated solutions than the stock concentrates used in percutaneous tests [see Preparation and Administration (2.1)].
Fire Ant: Use 0.02 mL of a 1:100,000 v/v dilution of the concentrate for intradermal tests. Very sensitive individuals such as those who have had nearly fatal anaphylactic reactions may not tolerate even 1:100,000 v/v dilution of concentrate as a starting point. These patients should be tested with a 1:10,000,000 v/v dilution of concentrate [see Preparation for Administration (2.1)].
Use intradermal tests following a negative or equivocal percutaneous test when the patient continues to report a history of symptoms following exposure to a specific allergen.
Administration
Intradermally inject 0.02 mL of the allergen using a 1 mL intradermal testing syringe with a 26 or 27 gauge, 1/2" or 3/8" needle with intradermal bevel, graduated in 0.01 units. Insert needle at a 30˚ angle, bevel down.
Test concurrently with a positive histamine control at intradermal strength (0.1 mg/mL of histamine base) and an aqueous buffer negative control (Sterile Albumin Saline with Phenol, Sterile Buffered Saline with Phenol).
Interpreting Results
For interpretation of intradermal skin tests, follow the information provided in Allergy Diagnostic Testing: An Updated Practice Parameter.1
- Measure wheal responses for the histamine positive control test and allergen tests at 10‑15 minutes after injection
- Response to the positive control should be at least 3 millimeters larger than the response to the negative control.
- The negative control (50% glycerin solution) response should measure < 3‑mm wheal and ≤ 10 mm flare (erythema).
- If either the response to the histamine positive control or to the negative control do not meet the criteria above for acceptable wheal size, the results for the allergenic extracts tested at the same time should be considered invalid and be repeated.
- Fire Ant: Intradermal testing is considered positive when the response occurs at a concentration of 1:1,000 w/v or less.4
2.3 Immunotherapy
For subcutaneous administration only.
Administration of Immunotherapy
Administer immunotherapy by subcutaneous injection in the lateral aspect of the arm or thigh. Avoid injection directly into any blood vessels. Administer injections with a sterile 1 mL allergy treatment syringe with a 26 or 27 gauge, 1/2", beveled needle, graduated in 0.01 units.
The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given one or two times per week until the maintenance dose is reached, at which time the injection interval is increased to 2, 3, and finally 4 weeks.
Most adverse reactions occur within 30 minutes after injection. Therefore, observe patients for at least 30 minutes. For high risk patients, 30 minutes of observation may not be sufficient.2
Dosing of non-standardized allergenic extracts for allergen immunotherapy is highly individualized. Adjust dose according to the degree of sensitivity of the patient, tolerance to the extract administered during the early phases of an injection regimen, and the clinical response. Dosing is individualized by choice of an initial dose, the schedule of dose build-up, the target maintenance dose, the actual maintenance dose, and the duration of treatment.
The large volume of solution for immunotherapy may produce increased discomfort in the pediatric population. In order to achieve the total dose required, the volume of the dose may need to be divided into more than one injection per visit.²
2.3.1 Dose Build-up
Following the first administration of 0.03 mL of the selected initial dilution of allergenic extract, dosing is increased in 0.03 mL to 0.12 mL increments until 0.3 mL is reached, following which 0.03 mL is administered from the next most concentrated allergen extract or allergen mixture vial in the dilution series. The interval between doses is usually 3 to 7 days during dose build-up. Proceed in this manner until a maintenance dose is reached. The final maintenance dose may not be the target maintenance dose selected at the beginning of therapy.
The following adjustments may be necessary during dose build-up:
- If allergic symptoms or local reactions develop shortly after dose administration, decrease the dose volume to one-half or one-quarter of the maximum dose previously attained.
- If the patient is experiencing any seasonal allergy symptoms, decrease the dose volume to one-half or one‑quarter of the maximum dose previously attained.
- Adjust the dose periodically based on the patient’s tolerance and reaction.
- Decrease the dose if the previous injection resulted in a marked local reaction.
- Repeat the previous dose or reduce the dose at the next administration if local reactions persist for longer than 24 hours.
- Decrease the dose if the previous injection resulted in a systemic reaction.Any evidence of a systemic reaction is an indication for a significant (at least 75%) reduction in the subsequent dose or the cessation of immunotherapy.
- Repeated systemic reactions, however mild, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose.
2.3.2 Maintenance Dose Selection, Adjustments, and Intervals
The maintenance dose is the dose that provides therapeutic efficacy without severe adverse local or systemic reactions. This dose may be limited by adverse reactions and may not be the original targeted maintenance dose. Select a maintenance dose based on the patient's clinical response and tolerance.
- Suggested maintenance dose is 0.3 mL of the undiluted allergen extract. Occasionally, higher doses are necessary to relieve symptoms.
- Maintenance doses larger than 0.3 mL of undiluted allergen extract may cause patient discomfort due to the 50% glycerin content.
- After the maintenance dose is achieved, increase the injection interval to 2 weeks, then 3 weeks, and finally 4 weeks, as tolerated. Administer the maintenance dose at a given interval three or four times before further increasing the interval to assure that no reactions occur. Protection may be lost rapidly if the interval between doses is more than 4 weeks.
The following adjustments to the maintenance dose may be necessary.
Withhold immunotherapy and/or reduce dosage, if any of the following conditions exist:
- Severe symptoms of rhinitis and/or asthma. Decrease dose to one-half or one-quarter of the maximum dose previously attained if the patient has any seasonal symptoms.
- Allergic symptoms or a local reaction following the prior dose.
- Infection accompanied by fever.
- Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
In situations prompting dose reduction, a cautious increase in dosage can be attempted once the reduced dose is tolerated.
Decrease the interval between doses if symptoms develop before the next injection is scheduled.
In some patients, the dosage may be increased and/or the dosing interval shortened based on individual responses and dosing requirements. If the onset of symptoms is soon after the initiation of immunotherapy, decrease the interval between each dose.
Changing to a different lot of extract: All extracts can lose allergenic activity over time and extracts vary in allergenic activity. Two different lots of extract could differ substantially in allergenic activity, even if they are the same formula and concentration. The volume of the first dose from the new vial should not exceed 50% of the previous dose. Do not use extracts beyond their expiry date.
Changing to a different formulation of extract or to an extract from a different manufacturer: Decrease the starting dose of the new extract when the extract is the same formula and dilution as the one previously used. In general, a volume dose reduction to 50% of the previous product dose is adequate, but each situation must be evaluated separately considering the patient's history of sensitivity, tolerance of previous injections, and other factors. If the patient tolerates the 50% decrease, then raise the next dose to the previous tolerated dose amount. To re-establish the maintenance dose the starting interval between doses should not be greater than one week.
Prolonged period has elapsed since the last injection: Patients may lose tolerance for allergen injections during prolonged intervals (> 4 weeks) between doses. The duration of tolerance is an individual characteristic and varies from patient to patient. In general, the longer the lapse in the injection schedule, the greater dose reduction required.
Changes made in the extract concentrate formula: Changes other than those listed above such as a difference in extracting fluid (e.g., change from non-glycerin extracts to 50% glycerin extracts), combining two or more stock concentrates, or any other change can affect a patient’s tolerance of the treatment. Extra dilutions are recommended whenever starting a revised formula. The greater the change, the greater the number of dilutions required.
Duration of Treatment
The duration of treatment for immunotherapy has not been established. A period of two to three years of injection therapy constitutes an average minimum course of treatment. Evaluate patients for treatment response at least every 6 to 12 months while they receive immunotherapy.
- 3 DOSAGE FORMS AND STRENGTHS
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4 CONTRAINDICATIONS
Non-standardized allergenic extracts are contraindicated in individuals with the following conditions:
- Severe, unstable or uncontrolled asthma.
- History of any severe systemic reaction to the allergen extract when administered for diagnosis or treatment.
- Medical conditions that reduce the ability to survive anaphylaxis.
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5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis
Anaphylaxis, which may lead to death, can occur in individuals following the administration of non-standardized allergenic extracts, particularly in the following situations:
- Extreme sensitivity to the non-standardized allergenic extract.
- Concomitant environmental exposure to allergens.
- Receipt of high doses of the non-standardized allergenic extract.
- Receipt of an accelerated build-up schedule (“rush” immunotherapy).
- Change from one lot of a particular non-standardized allergenic extract to another lot of the same non-standardized allergenic extract.
Administer non-standardized allergenic extracts in a healthcare setting under the supervision of a physician prepared to manage anaphylaxis; management may include use of inhaled bronchodilators and use of epinephrine. Non-standardized allergenic extracts may not be suitable for individuals who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. See prescribing information for epinephrine for complete information, particularly on medications that blunt or potentiate epinephrine activity. Individuals should remain in the physician’s office for a minimum of 30 minutes after receiving an injection of non‑standardized allergenic extracts, so that any adverse reaction can be observed and properly handled.
5.2 Cross-reactions and Dose Sensitivity
When determining the final dose of an allergen mixture for immunotherapy, consider cross-reactivity among component extracts.
Determine the initial dilution of allergenic extract, starting dose, and progression of dosage based on the patient’s history and results of skin tests [see Dosage and Administration (2)]. Strongly positive skin tests can be indicators for potential adverse reactions.
-
6 ADVERSE REACTIONS
Common adverse reactions reported for non-standardized allergenic extracts are:
- Local reactions occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy, at the injection site (e.g., erythema, swelling, pruritus, tenderness and pain).2
- Systemic adverse reactions, occurring in ≤ 7% of patients who receive subcutaneous immunotherapy (e.g., generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, hypotension, and shock).3 Systemic reactions may be fatal.2
No clinical trials of non-standardized allergenic extracts have been conducted.
Published studies of non-standardized allergenic extracts report systemic reactions occurring in fewer than 1% in patients receiving conventional immunotherapy and greater than 36% in patients receiving rush immunotherapy. Most systemic reactions occurred within 30 minutes of injection. However, systemic reactions have been reported to occur up to 2 hours after the final injection with rush schedules. Some reactions have occurred up to 6 hours after skin tests or immunotherapy.2, 3
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7 DRUG INTERACTIONS
7.1 Antihistamines
Do not perform skin testing with non-standardized allergenic extracts within 3 to 10 days of first-generation H1-histamine receptor blockers (e.g., clemastine, diphenhydramine) and second-generation antihistamines (e.g., loratadine, fexofenadine) being used. These products suppress histamine skin test reactions and could mask a positive response.1, 2
7.2 Topical Corticosteroids and Topical Anesthetics
Topical corticosteroids may suppress skin reactivity; therefore, discontinue use at the skin test site for at least 2 to 3 weeks before skin testing. Avoid use of topical local anesthetics at skin test sites because they can suppress flare responses.1, 2
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8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no human or animal data to establish the presence or absence of non-standardized allergenic extracts‑associated risks during pregnancy.
8.2 Lactation
Risk Summary
It is not known whether non-standardized allergenic extracts are present in human milk. Data are not available to assess the effects of these extracts on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for non-standardized allergenic extracts and any potential adverse effects on the breastfed child from the extracts or from the underlying maternal condition.
8.4 Pediatric Use
For use of these products in children younger than 5 years of age, consideration should be given to the patient’s ability to comply and cooperate with receipt of the product and the potential for difficulty in communicating with the child regarding systemic reactions.²
The volume of a dose for immunotherapy may need to be divided for pediatric patients [see Dosage and Administration (2.3)]
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11 DESCRIPTION
Non-standardized allergenic extracts are labeled “No U.S. Standard of Potency”.
Non-standardized allergenic extracts are supplied in a Glycero Cocas extraction solution, which consists of 0.5% sodium chloride for isotonicity, 0.275% sodium bicarbonate as a buffer, and 50% glycerin (volume/volume) as preservative.
Non-standardized allergenic extracts are supplied as a weight to volume (w/v) solution of allergen in extraction solution. Product concentrations vary based on the source. Refer to the vial label for the product concentration.
Source material mold mycelia and Candida albicans cells are cultivated on liquid medium which may contain one or more of the following constituents: casein hydrolysate; malt extract; yeast extract; maltose; dextrose; ammonium nitrate, calcium carbonate, calcium chloride, ammonium citrate, potassium phosphate, sodium citrate, citric acid; magnesium sulfate; or trace elements. Acetone and ether may be used as drying and de-fatting agents. Candida albicans cells are treated with phenol, which is removed by dialysis.
Dog Hair and Dander extracts are manufactured in 3 product forms:
- Dog Hair and Dander (Regular Process) is derived from extraction of the source material without additional processing, and is prepared at 1:10 w/v in Glycero-Cocas.
- Acetone Precipitated (AP) Dog Hair and Dander is derived from the acetone precipitated aqueous extract and is prepared at 1:100 w/v in Glycero-Cocas.
- Ultrafiltered (UF) Dog Hair and Dander is derived from the UF aqueous extract and is prepared at 1:650 w/v in Glycero‑Cocas.
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12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The skin test reaction results from interaction of the introduced allergen and allergen-specific IgE antibodies bound to mast cells, leading to mast cell degranulation and release of histamine, tryptase and other mediators, which results in the formation of the wheal and flare.
The precise mechanisms of action of allergen immunotherapy are not known. Immunologic responses to immunotherapy include changes in allergen-specific IgE levels, allergen-specific IgG levels, and regulatory T cell responses.2
- 14 CLINICAL STUDIES
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15 REFERENCES
1. Bernstein IL, Li JT, Bernstein Dl, et al. Allergy diagnostic testing: and updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100:S1-148.
2. Cox L, Nelson H, Lockey R, Calabria C, Chacko T, Finegold I, et al. Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol. 2011 Jan;127:S1-55.
3. Greineder DK. Risk management in allergen immunotherapy. J Allergy Clin Immunol. 1996 Dec;98(6 Pt 3):S330-4
4. Golden D B K, Demain J, Freeman T, Graft D, et al. Stinging insect hypersensitivity: A practice parameter update 2016. Ann Allergy Asthma Immunol 118 (2017) 28-54.
5. Federal Register Proposed Rule: Biological Products: Implementation of Efficacy Review, Allergenic Extracts, Federal Register 1985;50:3082-3288.
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16 HOW SUPPLIED
Non-standardized allergenic extracts and mixes are supplied as 50% glycerin stock concentrates labeled in weight/volume and provided in 10 milliliter, 30 milliliter and 50 milliliter vials for use in percutaneous skin testing and subcutaneous immunotherapy. These extracts may also be supplied in 5 milliliter dropper vials for percutaneous testing only.
These products are supplied as listed in Table 2.
TABLE 2: AVAILABLE PRODUCTS
POLLEN – GRASS ALLERGENS
Bahia Grass,Paspalum notatum
Brome, SmoothBromus inermis
Corn, CultivatedZea mays
Grass Mix 8-100,000 BAU/mL each ofP. pratensis; A. gigantean; P. pretense;10,000 BAU/mL ofC. dactylon; 1:20w/v ofS. halepense
Johnson Grass,Sorghum halepense
Oats, Common Cultivated,Avena sativa
POLLEN – TREE ALLERGENS
Acacia, Golden,Acacia longifolia
Alder, Red,Alnus rubra
Ash, White,Fraxinus americana
Beech, American,Fagus grandifolia
Birch Mix (PRW)-B. papyrifera, B. pendula, B. nigra
Bottlebrush,Melaleuca citrina
Boxelder/Maple Mix (BHR)-A. negundo, A. saccharum, A. rubrum
Cedar, Mountain,Juniperus ashei
Cedar, Red,Juniperus virginiana
Cottonwood, Common,Populus deltoides
Cyprus, Arizona,Cupressus arizonica
Cyprus, Bald,Taxodium distichum
Elm, American,Ulmus americana
Elm, Chinese,Ulmus parvifolia
Gum, Sweet,Liquidambar styraciflua
Hackberry,Celtis occidentalis
Hickory, Shagbark,Carya ovata
Maple, Hard/Sugar,Acer saccharum
Melaleuca,Melaleuca quinquenervia
Mesquite,Prosopis glandulosa
Mulberry Mix (RW)-M. rubra, M. alba
Oak Mix (RVW)-Q. rubra, Q. virginiana, Q. alba
Oak, Red,Quercus Rubra
Olive Tree,Olea europaea
Palm, Queen,Syagrus romanzoffiana
Pecan Tree,Carya illinoinensis
Pine Mix (LY)-P. contorta, P. ponderosa
Privet, Common,Ligustrum vilgare
Russian Olive,Elaeagnus angustifolia
Sycamore, American,Platanus occidentalis
Tree Mix 5-20% each ofF. Americana; J. nigra; P. deltoides; U. Americana;6.7% each ofB. papyrifera; B. nigra; B. pendula
Tree Mix 6- Tree Mix 6-20% each ofF. Americana; J. nigra; P. deltoides; U. Americana;6.7% each ofB. papyrifera; B. nigra; B. pendula
Tree Mix 11-10% each ofF. americana; B. nigra; J. nigra; P. deltoides; U. americana; C. ovata; A. saccharum; Q. rubra; P. occidentalis; S. nigra
Walnut, Black,Juglans nigra
Willow, Black,Salix nigra
POLLEN – WEED AND GARDEN PLANT ALLERGENS
Careless Weed,Amaranthus palmeri
Careless/Pigweed Mix (CR)-A. palmeri, A. retroflexus
Cocklebur, Common,Xanthium strumarium
Dock/Sorrel Mix (DS)-R. crispus, R. acetosella
Dog Fennel, Eastern,Eupatorium capillifolium
Goldenrod,Solidago canadensis
Kochia,Kochia scoparia
Lamb’s Quarters,Chenopodium album
Marshelder/Poverty Mix (BPT)-C. xanthifolia, I. annua, I. axillaris
Nettle,Urtica dioica
Pigweed, Rough Redroot,Amaranthus retroflexus
Plantain, English,Plantago lanceolata
Ragweed, Giant,Ambrosia trifida
Ragweed Mix (GSW)-A. trifida, A. artemisiifolia, A. psilostachya
Ragweed, Western,Ambrosia psilostachya
Russian Thistle,Salcola kali
Sagebrush, Mugwort,Artemisia vulgaris
Scale, Wing,Atriplex canescens
Sorrel, Sheep,Rumex acetosella
Weed Mix 2630-25% each ofX. strumarium; C. album; A. retroflexus;12.5% each ofR. crispus; R. acetosella
MOLDS
Alternaria/Hormodendrum Mix-A. tenuis, H. cladosporioides
Alternaria tenuis (Alternariaalternata)
Aspergillus fumigatus
Aspergillus niger var. niger
Botrytis cinerea
Candida albicans
Cephalosporium acremonium (Sarocladiumstrictum)
Curvularia spicifera (Cochliobolusspicifer)
Epicoccum nigrum
Epidermophyton floccosum
Fusarium vasinfectum (Fusariumoxysporumvasinfectum)
Heliminthosporium interseminatum (Dendryphiellavinosa)
Hormodendrum cladosporioides (Cladosporium cladosporioides)
Mold Mix 4-25% each ofA. alternata; C. cladosporioides;6.2% each ofA. fumigatus; A. nidulans; A. nigervar. niger; A. terreus; P. digitatum; P. expansum; P. chrysogenumvar. chrysogenum; C. rosea f. rosea
Mold Mix 10-2.5% each ofA. fumigatus; A. nidulans; A. nigervar. niger; A. terreus; P. digitatum; P. expansum; P. chrysogenumvar. chrysogenum; C. roseaf. rosea;10% each ofA. alternata; F. oxysporumvasinfectum; D. vinosa; C. cladosporioides; M. racemosus; P. exiguavar. exigua; A. pullulansvar. pullutans; R. stolonifer
Mucor racemosus
Penicillium Mix-P. expansum, P. digitatum, P. chrysogenum, C. rosea
Penicillium notatum (Penicilliumchrysogenumvar. chrysogenum)
Phoma herbarum (Phomaexiguavar. exigua)
Pullularia pullulans (Aerobasidiumpullulansvar. pullulans)
Rhizopus nigricans (Rhizopusstolonifer)
Stemphylium botryosum (Pleosporatarda)
Trichophyton Mix-T. tonsurans, T. rubrum , T. mentagrophytes
EPIDERMALS
AP Horse Hair and Dander,Equuscaballus
AP Cattle Hair and Dander,Bostaurus
AP Dog Hair and Dander,Canislupusfamiliaris
Dog Hair and Dander,Canislupusfamiliaris
UF Dog Hair and Dander,Canislupusfamiliaris
Feather Mix-G. gallus,A. platyrhynchos, A. anser
Guinea Pig Hair and Dander,Caviaporcellus
INSECTS
Cockroach, American,Periplanetaamericana
Cockroach, German,Blatellagermanica
Cockroach Mix-P. americana, B. germanica
Fire Ant,Solenopsisinvicta
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17 PATIENT COUNSELING INFORMATION
Instruct patients to remain in the office under observation for a minimum of 30 minutes after an injection or longer, if deemed necessary for the individual.
Inform patients that reactions may occur more than 30 minutes after skin testing or an injection.
Instruct patient to recognize the following symptoms as systemic adverse reactions and seek emergency medical care right away if any of these symptoms occur:
- Unusual swelling and/or tenderness at the injection site.
- Hives or itching of the skin.
- Swelling of face and/or mouth.
- Sneezing, coughing, or wheezing.
- Shortness of breath.
- Nausea.
- Dizziness or faintness.
Manufacturer:
Jubilant HollisterStier LLC
Spokane, WA 99207 U.S.A.
U.S. Lic. No. 1272
Version Date: February 24, 2022
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER
cattle hair and dander injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4811 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644) BOS TAURUS HAIR 0.01 g in 1 mL BOS TAURUS DANDER (UNII: C8VYS726O8) (BOS TAURUS DANDER - UNII:C8VYS726O8) BOS TAURUS DANDER 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4811-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4811-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4811-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 01/30/1978 ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP
animal allergens, dog dander canis spp injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4824 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.005 g in 1 mL CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4) CANIS LUPUS FAMILIARIS DANDER 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4824-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4824-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4824-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 08/24/1976 ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.
dog hair canis spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4083 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.05 g in 1 mL CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4) CANIS LUPUS FAMILIARIS DANDER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4083-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4083-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4083-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.
dog hair canis spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4085 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.05 g in 1 mL CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4) CANIS LUPUS FAMILIARIS DANDER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4085-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4085-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4085-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER
ap horse hair and dander injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4855 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS HAIR (UNII: 4F35XG0149) (EQUUS CABALLUS HAIR - UNII:4F35XG0149) EQUUS CABALLUS HAIR 0.01 g in 1 mL EQUUS CABALLUS DANDER (UNII: J81SZ18495) (EQUUS CABALLUS DANDER - UNII:J81SZ18495) EQUUS CABALLUS DANDER 0.01 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4855-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4855-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4855-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 01/30/1978 ANIMAL ALLERGENS, FEATHER MIX
feather mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4349 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.1 g in 1 mL ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.1 g in 1 mL ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4349-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4349-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4349-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 ANIMAL ALLERGENS, FEATHER MIX
feather mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4352 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.1 g in 1 mL ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.1 g in 1 mL ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4352-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4352-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-4352-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER
guinea pig hair and dander injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4401 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS HAIR (UNII: KBA5Y6X57N) (CAVIA PORCELLUS HAIR - UNII:KBA5Y6X57N) CAVIA PORCELLUS HAIR 0.05 g in 1 mL CAVIA PORCELLUS DANDER (UNII: 84Q71TU5SU) (CAVIA PORCELLUS DANDER - UNII:84Q71TU5SU) CAVIA PORCELLUS DANDER 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4401-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP.
beef bovine spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3077 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3077-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT GALLUS SP.
chicken meat gallus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3173 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POULTRY, UNSPECIFIED (UNII: L7WXO2P5HM) (POULTRY, UNSPECIFIED - UNII:L7WXO2P5HM) POULTRY, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3173-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OLIVE OLEA EUROPAEA
olive olea europaea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2053 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2053-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2053-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2053-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PALM, QUEEN COCOS PLUMOSA
palm, queen cocos plumosa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2074 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2074-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2074-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2074-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PALO VERDE CERCIDIUM FLORIDUM
palo verde cercidium floridum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2018 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PARKINSONIA FLORIDA POLLEN (UNII: 57586C96ZL) (PARKINSONIA FLORIDA POLLEN - UNII:57586C96ZL) PARKINSONIA FLORIDA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2018-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2018-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2018-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS
pecan carya carya illinoensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2098 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2098-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2098-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2098-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS
pecan carya carya illinoensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2101 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2101-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2101-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2101-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE
pepper tree, california schinus molle injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2107 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1) SCHINUS MOLLE POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2107-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2107-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2107-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PINE MIX
pine mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2203 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS CONTORTA POLLEN (UNII: FB7IP650ET) (PINUS CONTORTA POLLEN - UNII:FB7IP650ET) PINUS CONTORTA POLLEN 0.05 g in 1 mL PINUS PONDEROSA POLLEN (UNII: 042SUA2DS9) (PINUS PONDEROSA POLLEN - UNII:042SUA2DS9) PINUS PONDEROSA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2203-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2203-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2203-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, PRIVET LIGUSTRUM VULGARE
privet ligustrum vulgare injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2251 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2251-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2251-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2251-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA
russian olive elaeagnus angustifolia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2359 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELAEAGNUS ANGUSTIFOLIA POLLEN (UNII: 68P4F4M6VD) (ELAEAGNUS ANGUSTIFOLIA POLLEN - UNII:68P4F4M6VD) ELAEAGNUS ANGUSTIFOLIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2359-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2359-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2359-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, SYCAMORE, AMERICAN EASTERN PLATANUS OCCIDENTALLIS
sycamore, american eastern platanus occidentallis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2563 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2563-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2563-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2563-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 11
tree mix 11 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2619 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.05 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2619-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2619-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2619-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 11
tree mix 11 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2622 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.1 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.1 g in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.1 g in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.1 g in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.1 g in 1 mL CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.1 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.1 g in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.1 g in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.1 g in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2622-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2622-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2622-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 11
tree mix 11 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2624 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 20000 [PNU] in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 20000 [PNU] in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 20000 [PNU] in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 20000 [PNU] in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 20000 [PNU] in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 20000 [PNU] in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 20000 [PNU] in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2624-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2624-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2624-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 11
tree mix 11 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2623 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 40000 [PNU] in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 40000 [PNU] in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 40000 [PNU] in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 40000 [PNU] in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 40000 [PNU] in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 40000 [PNU] in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 40000 [PNU] in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 40000 [PNU] in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2623-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2623-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2623-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 5
tree mix 5 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2854 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.017 g in 1 mL ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.017 g in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.017 g in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.017 g in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.017 g in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.017 g in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2854-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2854-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2854-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 5
tree mix 5 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2856 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.1 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.033 g in 1 mL ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.033 g in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.033 g in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.033 g in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.033 g in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.033 g in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.1 g in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2856-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2856-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2856-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 5
tree mix 5 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2855 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 20000 [PNU] in 1 mL ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 20000 [PNU] in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 20000 [PNU] in 1 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 20000 [PNU] in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 20000 [PNU] in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 20000 [PNU] in 1 mL SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2855-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2855-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2855-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 6
tree mix 6 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2863 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.017 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.017 g in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 0.017 g in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2863-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2863-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2863-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 6
tree mix 6 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2861 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.1 g in 1 mL BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.033 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.033 g in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 0.033 g in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.1 g in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.1 g in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2861-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2861-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2861-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE MIX 6
tree mix 6 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2862 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 20000 [PNU] in 1 mL BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 20000 [PNU] in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 20000 [PNU] in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 20000 [PNU] in 1 mL JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 20000 [PNU] in 1 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2862-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2862-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2862-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA
tree of heaven ailanthus altissima injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2599 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2599-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2599-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2599-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA
walnut, black juglans nigra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2626 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2626-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2626-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2626-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA
walnut, black juglans nigra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2629 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2629-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2629-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2629-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, WILLOW, BLACK SALIX NIGRA
willow, black salix nigra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2677 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2677-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2677-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2677-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM
cocklebur xanthium strumarium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1405 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1405-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1405-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1405-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM
cocklebur xanthium strumarium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1408 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1408-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1408-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1408-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM
cocklebur xanthium strumarium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1409 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1409-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1409-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1409-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, DOG FENNEL, EASTERN EUPATORIUM CAPILLIFOLIUM
dog fennel, eastern eupatorium capillifolium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2057 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2057-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2057-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2057-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS
goldenrod solidago canadensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1630 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1630-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1630-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1630-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, LAMBS QUARTERS CHENOPODIUM ALBUM
lambs quarters chenopodium album injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1786 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1786-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1786-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1786-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, LAMBS QUARTERS CHENOPODIUM ALBUM
lambs quarters chenopodium album injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1789 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1789-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1789-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1789-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, LAMBS QUARTERS CHENOPODIUM ALBUM
lambs quarters chenopodium album injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1790 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1790-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1790-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1790-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, LAMBS QUARTERS CHENOPODIUM ALBUM
lambs quarters chenopodium album injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1791 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1791-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1791-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1791-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, NETTLE URTICA DIOICA
nettle urtica dioica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1945 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1945-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1945-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1945-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, NETTLE URTICA DIOICA
nettle urtica dioica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1947 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1947-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1947-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1947-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS
pigweed, rough redroot amaranthus retroflexus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2125 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2125-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2125-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2125-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
plantain, english plantago lanceolata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2212 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2212-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2212-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2212-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
plantain, english plantago lanceolata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2215 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2215-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2215-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2215-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
plantain, english plantago lanceolata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2217 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2217-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2217-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2217-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA
plantain, english plantago lanceolata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2216 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2216-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2216-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2216-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA
ragweed, giant ambrosia trifida injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2293 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2293-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2293-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2293-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA
ragweed, giant ambrosia trifida injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2296 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2296-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2296-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2296-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA
ragweed. western ambrosia psilostachya injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2308 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2308-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2308-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2308-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA
ragweed. western ambrosia psilostachya injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2311 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2311-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2311-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2311-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI
russian thistle salsola kali injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2362 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2362-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2362-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2362-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS
sagebrush, mugwort artemisia vulgaris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2413 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2413-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2413-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2413-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS
sagebrush, mugwort artemisia vulgaris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2416 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2416-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2416-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2416-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS
sagebrush, mugwort artemisia vulgaris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2417 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2417-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2417-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2417-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX CANESCENS
scale, wing shad atriplex canescens injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2482 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (ATRIPLEX CANESCENS POLLEN - UNII:26U0BU8G83) ATRIPLEX CANESCENS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2482-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2482-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2482-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING SHAD ATRIPLEX CANESCENS
scale, wing shad atriplex canescens injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2485 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (ATRIPLEX CANESCENS POLLEN - UNII:26U0BU8G83) ATRIPLEX CANESCENS POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2485-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2485-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2485-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS
scotch broom cytisus scoparius injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2487 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYTISUS SCOPARIUS FLOWERING TOP (UNII: XZC6H8R666) (CYTISUS SCOPARIUS FLOWERING TOP - UNII:XZC6H8R666) CYTISUS SCOPARIUS FLOWERING TOP 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2487-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2487-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2487-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA
sorrel, sheep rumex acetosella injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2506 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2506-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2506-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2506-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA
sorrel, sheep rumex acetosella injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2508 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2508-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2508-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2508-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI
careless weed amaranthus palmeri injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1297 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1297-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1297-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1297-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, CARELESS/PIGWEED MIX
careless/pigweed mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1300 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1300-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1300-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1300-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, CARELESS/PIGWEED MIX
careless/pigweed mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1303 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.1 g in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1303-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1303-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1303-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, DOCK/SORREL MIX
pollens - weeds, dock/sorrel mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1516 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1516-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1516-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1516-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, DOCK/SORREL MIX
pollens - weeds, dock/sorrel mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1519 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.1 g in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1519-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1519-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1519-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, DOCK/SORREL MIX
pollens - weeds, dock/sorrel mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1520 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 20000 [PNU] in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1520-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1520-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1520-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX
giant, short, western ragweed mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2320 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2320-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2320-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2320-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, KOCHIA SCOPARIA
kochia scoparia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1780 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1780-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1780-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1780-5 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, KOCHIA SCOPARIA
kochia scoparia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1783 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1783-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1783-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1783-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, MARSHELDER/POVERTY MIX
pollens - weeds, marshelder/poverty mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1858 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA AXILLARIS POLLEN (UNII: 13KFG30UBR) (IVA AXILLARIS POLLEN - UNII:13KFG30UBR) IVA AXILLARIS POLLEN 0.05 g in 1 mL IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.05 g in 1 mL CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1858-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1858-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1858-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, MARSHELDER/POVERTY MIX
pollens - weeds, marshelder/poverty mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1861 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA AXILLARIS POLLEN (UNII: 13KFG30UBR) (IVA AXILLARIS POLLEN - UNII:13KFG30UBR) IVA AXILLARIS POLLEN 0.1 g in 1 mL IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.1 g in 1 mL CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1861-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1861-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1861-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, WEED MIX 2630
weed mix 2630 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2634 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 0.05 g in 1 mL CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.025 g in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2634-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2634-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2634-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, WEED MIX 2630
weed mix 2630 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2632 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 0.1 g in 1 mL CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.1 g in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.1 g in 1 mL RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2632-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2632-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2632-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, WEED MIX 2630
weed mix 2630 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2635 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 20000 [PNU] in 1 mL CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 20000 [PNU] in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU] in 1 mL RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 20000 [PNU] in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2635-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2635-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2635-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - WEEDS, WEED MIX 2630
weed mix 2630 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2633 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 40000 [PNU] in 1 mL CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU] in 1 mL RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 40000 [PNU] in 1 mL RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2633-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2633-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2633-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, WHITE GALLUS SP.
egg, white gallus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3248 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE (UNII: 3E0I92Z2GR) (EGG WHITE - UNII:3E0I92Z2GR) EGG WHITE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3248-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, YOLK GALLUS SP.
egg, yolk gallus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3254 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK (UNII: 4IPS17B70T) (EGG YOLK - UNII:4IPS17B70T) EGG YOLK 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3254-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, PORK SUS SP.
pork sus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3509 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3509-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - DAIRY PRODUCTS, CASEIN, COW MILK
casein, cow milk injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3380 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASEIN (UNII: 48268V50D5) (CASEIN - UNII:48268V50D5) CASEIN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3380-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - DAIRY PRODUCTS, MILK, WHOLE COW
milk, whole cow injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3389 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3389-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, CLAM
clam injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3191 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUAHOG, UNSPECIFIED (UNII: 226LY0AFR9) (QUAHOG, UNSPECIFIED - UNII:226LY0AFR9) QUAHOG, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3191-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, CODFISH GADUS CALLARIAS
codfish gadus callarias injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3203 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COD, UNSPECIFIED (UNII: 8D6Q5LNG3D) (COD, UNSPECIFIED - UNII:8D6Q5LNG3D) COD, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3203-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI
crab xiphosurus sowerbyi injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3215 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRAB LEG, UNSPECIFIED (UNII: S1VF61QLO9) (CRAB LEG, UNSPECIFIED - UNII:S1VF61QLO9) CRAB LEG, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3215-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, LOBSTER HOMARUS AMERICANUS
lobster homarus americanus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3362 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOBSTER, UNSPECIFIED (UNII: ZQ6LG2C39M) (LOBSTER, UNSPECIFIED - UNII:ZQ6LG2C39M) LOBSTER, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3362-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, SALMON SALMO SALAR
salmon salmo salar injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3565 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALMON, UNSPECIFIED (UNII: 6122W2M0GB) (SALMON, UNSPECIFIED - UNII:6122W2M0GB) SALMON, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3565-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, SHRIMP CRAGO SP.
shrimp crago sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3584 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SHRIMP, UNSPECIFIED (UNII: 1891LE191T) (SHRIMP, UNSPECIFIED - UNII:1891LE191T) SHRIMP, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3584-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - FISH AND SHELLFISH, TUNA THUNNUS SP.
tuna thunnus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3674 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TUNA, UNSPECIFIED (UNII: V2T3IHT3E2) (TUNA, UNSPECIFIED - UNII:V2T3IHT3E2) TUNA, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3674-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, ALMOND PRUNUS AMYGDALUS
almond prunus amygdalus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3014 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) ALMOND 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3014-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, APPLE MALUS SP.
apple malus sp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3020 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APPLE (UNII: B423VGH5S9) (APPLE - UNII:B423VGH5S9) APPLE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3020-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, BANANA MUSA SAPIENTUM
banana musa sapientum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3041 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3041-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, BRAZIL NUT BERTHOLLETIA EXCELSA
brazil nut bertholletia excelsa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3107 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K) BRAZIL NUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3107-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, CARROT DAUCUS CAROTA
carrot daucus carota injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3125 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARROT (UNII: L56Z1JK48B) (CARROT - UNII:L56Z1JK48B) CARROT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3125-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, CASHEW NUT ANACARDIUM OCCIDENTALIE
cashew nut anacardium occidentalie injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3134 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO) CASHEW 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3134-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, CELERY APIUM GRAVEOLENS
celery apium graveolens injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3140 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELERY (UNII: 44IDY6DTKX) (CELERY - UNII:44IDY6DTKX) CELERY 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3140-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, CORN ZEA MAYS
corn zea mays injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3212 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3212-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, HAZELNUT FILBERT CORYLUS SPP.
hazelnut filbert corylus spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3305 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAZELNUT, UNSPECIFIED (UNII: IW0OM96F6O) (HAZELNUT, UNSPECIFIED - UNII:IW0OM96F6O) HAZELNUT, UNSPECIFIED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3305-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO
cantaloupe cucumis melo injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3116 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANTALOUPE (UNII: 8QF5D5H6UH) (CANTALOUPE - UNII:8QF5D5H6UH) CANTALOUPE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3116-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, ORANGE CITRUS SINENSIS
orange citrus sinensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3428 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3428-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM
pea, green or english pisum sativum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3449 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEA (UNII: W4X7H8GYFM) (PEA - UNII:W4X7H8GYFM) PEA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3449-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, PEACH PRUNUS PERSICA
peach prunus persica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3452 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEACH (UNII: 3OKE88I3QG) (PEACH - UNII:3OKE88I3QG) PEACH 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3452-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, PEANUT ARACHIS HYPOGAEA
peanut arachis hypogaea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3455 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3455-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, PECAN CARYA ILLINOENSIS
pecan carya illinoensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3461 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3461-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM
potato, white solanum tuberosum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3518 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3518-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, RICE, WHOLE GRAIN
rice, whole grain injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3548 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG) BROWN RICE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3548-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, RYE GRAIN
rye grain injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3554 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3554-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, SOYBEAN GLYCINE SOJA
soybean glycine soja injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3596 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3596-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, STRAWBERRY FRAGARIA CHILOENSIS
strawberry fragaria chiloensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3626 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRAWBERRY (UNII: 4J2TY8Y81V) (STRAWBERRY - UNII:4J2TY8Y81V) STRAWBERRY 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3626-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, STRING BEAN MIX
string bean mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3074 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRING BEAN (UNII: N9D69B2Q7Y) (STRING BEAN - UNII:N9D69B2Q7Y) STRING BEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3074-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, TOMATO NICOTIANA SPP.
tomato nicotiana spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3656 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3656-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, WALNUT, BLACK JUGLANS NIGRA
walnut, black juglans nigra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3695 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK WALNUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3695-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, YEAST, BAKER SACCHAROMYCES CEREVISIAE
yeast, baker saccharomyces cerevisiae injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3713 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength YEAST (UNII: 3NY3SM6B8U) (YEAST - UNII:3NY3SM6B8U) YEAST 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3713-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 FOOD - PLANT SOURCE, YEAST, BREWER SACCHAROMYCES CEREVISIAE
yeast, brewer saccharomyces cerevisiae injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-3716 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength YEAST (UNII: 3NY3SM6B8U) (YEAST - UNII:3NY3SM6B8U) YEAST 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-3716-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH, AMERICAN PERIPLANETA AMERICANA
insects whole body cockroach, american periplaneta americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6580 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6580-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6580-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6580-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH, GERMAN BLATELLA GERMANICA
insects whole body cockroach, german blatella germanica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6581 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6581-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6581-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6581-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH MIX
insects whole body cockroach mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6584 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.1 g in 1 mL BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6584-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6584-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6584-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH MIX
insects whole body cockroach mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6587 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.1 g in 1 mL BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6587-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6587-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6587-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH MIX
insects whole body cockroach mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6588 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 20000 [PNU] in 1 mL BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6588-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6588-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6588-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH MIX
insects whole body cockroach mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6589 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 20000 [PNU] in 1 mL BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6589-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6589-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6589-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY COCKROACH MIX
insects whole body cockroach mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6590 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 5000 [PNU] in 1 mL BLATTELLA GERMANICA (UNII: G9O67I0A8Q) (BLATTELLA GERMANICA - UNII:G9O67I0A8Q) BLATTELLA GERMANICA 5000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6590-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6590-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6590-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY, FIRE ANT MIX
insects whole body, fire ant mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6518 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLENOPSIS RICHTERI (UNII: 739684T11W) (SOLENOPSIS RICHTERI - UNII:739684T11W) SOLENOPSIS RICHTERI 0.1 g in 1 mL SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444) SOLENOPSIS INVICTA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6518-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6518-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6518-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY, FIRE ANT MIX
insects whole body, fire ant mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6517 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLENOPSIS RICHTERI (UNII: 739684T11W) (SOLENOPSIS RICHTERI - UNII:739684T11W) SOLENOPSIS RICHTERI 0.1 g in 1 mL SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444) SOLENOPSIS INVICTA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6517-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-6517-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-6517-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS - ALTERNARIA/HORMODENDRUM MIX
molds - alternaria/hormodendrum mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5004 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5004-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5004-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5004-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS - MOLD MIX 10
molds - mold mix 10 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5136 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.025 g in 1 mL ASPERGILLUS NIDULANS (UNII: 242A53RB80) (ASPERGILLUS NIDULANS - UNII:242A53RB80) ASPERGILLUS NIDULANS 0.025 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.025 g in 1 mL ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X) ASPERGILLUS TERREUS 0.025 g in 1 mL FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.1 g in 1 mL DENDRYPHIELLA VINOSA (UNII: 7S6NW5FH8X) (DENDRYPHIELLA VINOSA - UNII:7S6NW5FH8X) DENDRYPHIELLA VINOSA 0.1 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.1 g in 1 mL PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239) PENICILLIUM DIGITATUM 0.02 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.02 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.02 g in 1 mL CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H) CLONOSTACHYS ROSEA F. ROSEA 0.02 g in 1 mL PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.1 g in 1 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g in 1 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5136-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5136-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5136-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS - MOLD MIX 4
molds - mold mix 4 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5000 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.025 g in 1 mL ASPERGILLUS NIDULANS (UNII: 242A53RB80) (ASPERGILLUS NIDULANS - UNII:242A53RB80) ASPERGILLUS NIDULANS 0.025 g in 1 mL ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.025 g in 1 mL ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X) ASPERGILLUS TERREUS 0.025 g in 1 mL CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239) PENICILLIUM DIGITATUM 0.025 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.025 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.025 g in 1 mL CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H) CLONOSTACHYS ROSEA F. ROSEA 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5000-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5000-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5000-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS - TRICHOPHYTON MIX
molds - trichophyton mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5284 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON TONSURANS (UNII: JY1BE33I3Y) (TRICHOPHYTON TONSURANS - UNII:JY1BE33I3Y) TRICHOPHYTON TONSURANS 0.1 g in 1 mL TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 0.1 g in 1 mL TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5284-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5284-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5284-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, PENICILLIUM MIX
molds, penicillium mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5168 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM DIGITATUM (UNII: 1SB49SV239) (PENICILLIUM DIGITATUM - UNII:1SB49SV239) PENICILLIUM DIGITATUM 0.1 g in 1 mL PENICILLIUM EXPANSUM (UNII: 1XSC3BB35Z) (PENICILLIUM EXPANSUM - UNII:1XSC3BB35Z) PENICILLIUM EXPANSUM 0.1 g in 1 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL CLONOSTACHYS ROSEA F. ROSEA (UNII: I5F729WZ2H) (CLONOSTACHYS ROSEA F. ROSEA - UNII:I5F729WZ2H) CLONOSTACHYS ROSEA F. ROSEA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5168-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5168-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5168-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS
alternaria tenuis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5008 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5008-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5008-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5008-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS
aspergillus fumigatus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5020 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5020-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5020-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5020-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, ASPERGILLUS NIGER
aspergillus niger injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5032 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5032-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5032-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5032-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA
botrytis cinerea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5048 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5048-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5048-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5048-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 INSECTS WHOLE BODY, ANT, FIRE SOLENOPSIS INVICTA
ant, fire solenopsis invicta injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-6513 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444) SOLENOPSIS INVICTA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6513-2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS
candida albicans injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5052 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5052-1 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5052-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5052-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS
candida albicans injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5055 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.001 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5055-1 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5055-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5055-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM
cephalosporium acremonium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5056 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5056-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5056-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5056-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA
curvularia spicifera injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5076 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5076-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5076-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5076-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM
epicoccum nigrum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5100 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5100-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5100-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5100-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, EPIDERMOPHYTON FLOCCOSUM
epidermophyton floccosum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5104 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPIDERMOPHYTON FLOCCOSUM (UNII: 6JR6JTN25S) (EPIDERMOPHYTON FLOCCOSUM - UNII:6JR6JTN25S) EPIDERMOPHYTON FLOCCOSUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5104-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5104-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5104-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM
fusarium vasinfectum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5112 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5112-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5112-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5112-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM
helminthosporium interseminatum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5124 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DENDRYPHIELLA VINOSA (UNII: 7S6NW5FH8X) (DENDRYPHIELLA VINOSA - UNII:7S6NW5FH8X) DENDRYPHIELLA VINOSA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5124-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5124-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5124-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES
hormodendrum cladosporioides injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5128 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5128-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5128-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5128-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS
mucor racemosus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5144 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5144-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5144-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5144-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM
penicillium notatum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5208 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5208-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5208-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5208-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM
phoma herbarum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5220 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5220-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5220-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5220-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS
pullularia pullulans injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5235 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5235-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5235-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5235-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS
rhizopus nigricans injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5230 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5230-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5230-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5230-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM
stemphylium botryosum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-5264 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA TARDA (UNII: TPL549N9R8) (PLEOSPORA TARDA - UNII:TPL549N9R8) PLEOSPORA TARDA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5264-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-5264-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-5264-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM
bahia grass paspalum notatum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1081 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1081-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1081-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1081-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM
bahia grass paspalum notatum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1084 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1084-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1084-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1084-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, BROME, SMOOTH BROMUS INERMIS
brome, smooth bromus inermis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1237 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1237-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1237-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1237-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, CORN, CULTIVATED ZEA MAYS
corn, cultivated zea mays injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1414 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1414-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1414-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1414-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE
johnson grass sorghum halepense injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1744 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1744-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1744-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1744-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE
johnson grass sorghum halepense injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1747 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1747-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1747-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1747-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA
oats, common, cultivated avena sativa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2041 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7) AVENA SATIVA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2041-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2041-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2041-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, GRASS MIX 8
grass mix 8 injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-0879 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 100000 [BAU] in 1 mL CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 100000 [BAU] in 1 mL PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 100000 [BAU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0879-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, SOUTHERN GRASS MIX
pollens - grasses, southern grass mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-0854 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 100000 [BAU] in 1 mL DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 100000 [BAU] in 1 mL AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 100000 [BAU] in 1 mL PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 100000 [BAU] in 1 mL ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU] in 1 mL SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0854-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-0854-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-0854-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - GRASSES, SOUTHERN GRASS MIX
pollens - grasses, southern grass mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-0856 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN 10000 [BAU] in 1 mL DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN 10000 [BAU] in 1 mL AGROSTIS GIGANTEA POLLEN (UNII: HU8V6E7HOA) (AGROSTIS GIGANTEA POLLEN - UNII:HU8V6E7HOA) AGROSTIS GIGANTEA POLLEN 10000 [BAU] in 1 mL PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) PHLEUM PRATENSE POLLEN 10000 [BAU] in 1 mL ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU] in 1 mL SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.005 g in 1 mL CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON POLLEN - UNII:175F461W10) CYNODON DACTYLON POLLEN 1000 [BAU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-0856-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-0856-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-0856-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ACACIA ACACIA LONGIFOLIA
acacia longifolia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1006 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA LONGIFOLIA POLLEN (UNII: 24SO2J296O) (ACACIA LONGIFOLIA POLLEN - UNII:24SO2J296O) ACACIA LONGIFOLIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1006-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1006-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1006-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ALDER, RED ALNUS RUBRA
alder, red alnus rubra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1018 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H) ALNUS RUBRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1018-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1018-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1018-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ALDER, RED ALNUS RUBRA
alder, red alnus rubra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1021 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H) ALNUS RUBRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1021-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1021-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1021-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA
ash, white fraxinus americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1060 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1060-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1060-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1060-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BEECH, AMERICAN FAGUS GRANDIFOLIA
beech, american fagus grandifolia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1120 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1120-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1120-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1120-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BIRCH MIX
birch mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1168 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.05 g in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 0.05 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1168-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1168-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1168-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BIRCH MIX
birch mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1171 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.1 g in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 0.1 g in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1171-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1171-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1171-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BIRCH MIX
birch mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1172 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 20000 [PNU] in 1 mL BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN 40000 [PNU] in 1 mL BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1172-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1172-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1172-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BOTTLE BRUSH CALLISTEMON SPP.
bottle brush callistemon spp. injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1207 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA CITRINA POLLEN (UNII: 62OII98F1T) (MELALEUCA CITRINA POLLEN - UNII:62OII98F1T) MELALEUCA CITRINA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1207-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1207-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1207-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BOXELDER/MAPLE MIX
boxelder/maple mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1213 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.05 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1213-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1213-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1213-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BOXELDER/MAPLE MIX
boxelder/maple mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1216 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.1 g in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.1 g in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1216-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1216-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1216-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, BOXELDER/MAPLE MIX
boxelder/maple mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1217 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 40000 [PNU] in 1 mL ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 40000 [PNU] in 1 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1217-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1217-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1217-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI
cedar, mountain juniperus ashei injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1336 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1336-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1336-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1336-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI
cedar, mountain juniperus ashei injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1339 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1339-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1339-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1339-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA
cedar, red juniperus virginiana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1343 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1343-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1343-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1343-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA
cedar, red juniperus virginiana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1342 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1342-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1342-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1342-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES
cottonwood, common populus deltoides injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1435 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1435-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1435-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1435-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES
cottonwood, common populus deltoides injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1438 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1438-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1438-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1438-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CYPRESS, ARIZONA CUPRESSUS ARIZONICA
cypress, arizona cupressus arizonica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1450 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1450-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1450-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1450-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, CYPRESS, BALD TAXODIUM DISTICHUM
cypress, bald taxodium distichum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1453 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.02 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1453-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1453-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1453-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA
elm, american ulmus americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1540 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1540-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1540-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1540-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA
elm, american ulmus americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1543 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1543-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1543-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1543-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA
elm, american ulmus americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1544 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1544-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1544-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1544-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA
elm, chinese ulmus parvifolia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1546 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PARVIFOLIA POLLEN (UNII: IU0Z41653U) (ULMUS PARVIFOLIA POLLEN - UNII:IU0Z41653U) ULMUS PARVIFOLIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1546-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1546-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1546-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, EUCALYPTUS, EUCALYPTUS GLOBULUS
eucalyptus, eucalyptus globulus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1564 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1564-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1564-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1564-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA
gum, sweet liquidambar styraciflua injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1660 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1660-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1660-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1660-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA
gum, sweet liquidambar styraciflua injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1662 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1662-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1662-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1662-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS
hackberry celtis occidentalis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1663 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1663-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1663-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1663-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, HICKORY, SHAGBARK CARYA OVATA
hickory, shagbark carya ovata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1702 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1702-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1702-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1702-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, LINDEN BASSWOOD TILIA AMERICANA
linden basswood tilia americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1801 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TILIA AMERICANA POLLEN (UNII: E2B4Q4BXJG) (TILIA AMERICANA POLLEN - UNII:E2B4Q4BXJG) TILIA AMERICANA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1801-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1801-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1801-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, MAPLE, HARD ACER SACCHARUM
maple, hard acer saccharum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1831 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1831-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1831-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1831-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, MELALEUCA PUNK TREE MELALEUCA QUINQUENERVIA
melaleuca punk tree melaleuca quinquenervia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1873 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1873-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1873-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1873-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA
mesquite, prosopis juliflora injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1876 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1876-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1876-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1876-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, MULBERRY MIX
mulberry mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1909 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.05 g in 1 mL MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1909-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1909-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1909-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, MULBERRY MIX
mulberry mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-1912 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.1 g in 1 mL MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1912-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-1912-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-1912-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OAK MIX
oak mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2035 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.05 g in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2035-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2035-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2035-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OAK MIX
oak mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2038 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.1 g in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.1 g in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2038-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2038-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2038-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OAK MIX
oak mix injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2039 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 20000 [PNU] in 1 mL QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 20000 [PNU] in 1 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2039-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2039-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2039-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OAK, RED QUERCUS RUBRA
oak, red quercus rubra injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2014 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2014-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2014-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2014-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 POLLENS - TREES, OLIVE OLEA EUROPAEA
olive olea europaea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-2050 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2050-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-2050-3 30 mL in 1 VIAL; Type 0: Not a Combination Product 3 NDC:65044-2050-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 04/19/1941 ANIMAL ALLERGENS, UF DOG HAIR-DANDER CANIS SPP
animal allergens, dog dander canis spp injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:65044-4850 Route of Administration PERCUTANEOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 0.0008 g in 1 mL CANIS LUPUS FAMILIARIS DANDER (UNII: 11JCK302I4) (CANIS LUPUS FAMILIARIS DANDER - UNII:11JCK302I4) CANIS LUPUS FAMILIARIS DANDER 0.0008 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4850-2 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:65044-4850-4 50 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 07/01/2022 Labeler - Jubilant HollisterStier LLC (069263643) Registrant - Jubilant HollisterStier LLC - HollisterStier Allergy (119241112)