Label: ALMOND- prunus dulcis injection, solution
APPLE- malus domestica injection, solution
APRICOT- prunus armeniaca injection, solution
ASPARAGUS- asparagus officinalis injection, solution
AVOCADO- persea americana injection, solution
BANANA- musa sapientum injection, solution
TURKEY- meleagris gallopavo injection, solution
VANILLA- vanilla planifolia injection, solution
VITIS SPP injection, solution
WATERMELON- citrullus lanatus injection, solution
WHEAT GRAIN- triticum aestivum injection, solution
WHITE POTATO- solanum tuberosum injection, solution
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NDC Code(s):
0268-6100-06,
0268-6100-10,
0268-6101-06,
0268-6101-10, view more0268-6102-06, 0268-6103-06, 0268-6104-06, 0268-6104-10, 0268-6105-06, 0268-6105-10, 0268-6106-06, 0268-6106-10, 0268-6107-06, 0268-6107-10, 0268-6108-06, 0268-6108-10, 0268-6109-06, 0268-6109-10, 0268-6110-06, 0268-6110-10, 0268-6112-06, 0268-6113-06, 0268-6113-10, 0268-6114-06, 0268-6115-06, 0268-6115-10, 0268-6116-06, 0268-6116-10, 0268-6118-06, 0268-6118-10, 0268-6120-06, 0268-6120-10, 0268-6121-06, 0268-6121-10, 0268-6122-06, 0268-6122-10, 0268-6123-06, 0268-6123-10, 0268-6124-06, 0268-6124-10, 0268-6125-06, 0268-6125-10, 0268-6127-06, 0268-6127-10, 0268-6128-06, 0268-6128-10, 0268-6129-06, 0268-6129-10, 0268-6130-06, 0268-6130-10, 0268-6132-06, 0268-6133-06, 0268-6133-10, 0268-6135-06, 0268-6135-10, 0268-6136-06, 0268-6136-10, 0268-6137-06, 0268-6138-06, 0268-6138-10, 0268-6139-06, 0268-6139-10, 0268-6141-06, 0268-6146-06, 0268-6149-06, 0268-6149-10, 0268-6170-06, 0268-6171-06, 0268-6171-10, 0268-6173-06, 0268-6174-06, 0268-6174-10, 0268-6177-06, 0268-6178-06, 0268-6178-10, 0268-6180-06, 0268-6180-10, 0268-6181-06, 0268-6181-10, 0268-6183-06, 0268-6183-10, 0268-6185-06, 0268-6186-06, 0268-6186-10, 0268-6187-06, 0268-6187-10, 0268-6189-06, 0268-6189-10, 0268-6191-06, 0268-6191-10, 0268-6192-06, 0268-6192-10, 0268-6193-06, 0268-6193-10, 0268-6195-06, 0268-6196-06, 0268-6196-10, 0268-6197-06, 0268-6198-06, 0268-6198-10, 0268-6200-06, 0268-6200-10, 0268-6202-06, 0268-6202-10, 0268-6203-06, 0268-6204-06, 0268-6204-10, 0268-6205-06, 0268-6205-10, 0268-6206-06, 0268-6206-10, 0268-6208-06, 0268-6208-10, 0268-6210-06, 0268-6210-10, 0268-6212-06, 0268-6212-10, 0268-6213-06, 0268-6213-10, 0268-6214-06, 0268-6214-10, 0268-6216-06, 0268-6216-10, 0268-6218-06, 0268-6219-06, 0268-6220-06, 0268-6220-10, 0268-6221-06, 0268-6221-10, 0268-6224-06, 0268-6224-10, 0268-6226-06, 0268-6226-10, 0268-6229-06, 0268-6229-10, 0268-6230-06, 0268-6231-06, 0268-6231-10, 0268-6233-06, 0268-6234-06, 0268-6234-10, 0268-6235-06, 0268-6235-10, 0268-6236-10, 0268-7130-06, 0268-8043-06, 0268-8044-10, 0268-8061-06, 0268-8062-10
- Packager: ALK-Abello, Inc.
- Category: NON-STANDARDIZED ALLERGENIC LABEL
- DEA Schedule: None
- Marketing Status: Biologic Licensing Application
Drug Label Information
Updated May 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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BOXED WARNING
(What is this?)
WARNING
This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist.
As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life-threatening reactions may result in death. Fatalities associated with skin testing have been reported. Patients should be observed for at least 20 - 30 minutes following testing. Emergency measures and adequately trained personnel should be immediately available in the event of a life-threatening reaction.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction.
Sensitive patients may experience severe anaphlactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. This product should not be injected intravenously. Patients receiving beta blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for the treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections below.
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer.
Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety. Molds are individwually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety.
Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously.
Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline or glycerin, filtered aseptically and after final packaging are tested for sterility and safety.
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CLINICAL PHARMACOLOGY
Diagnostically (for skin testing) the allergen combines with IgE antibodies fixed to mast cells in the skin. This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.1 The more mediator release, the larger the reaction (wheal and erythema).
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INDICATIONS AND USAGE
These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response, the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use. Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.
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CONTRAINDICATIONS
Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNING statement and ADVERSE REACTIONS). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise.
Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction2,3. See also PRECAUTIONS and ADVERSE REACTIONS.
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WARNINGS
Severe Allergic Reactions:
Patients should always be observed for at least 20 - 30 minutes after skin testing. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstruction, hypotension, coma and death (see ADVERSE REACTIONS), applications of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15-minute intervals. Patients under treatment with beta blockers may be refractory to the usual dose of epinephrine.
Volume expanders and vasopressor agents may be required to reverse hypotension, inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In case of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.
Anaphylaxis Following False Negative Food Allergen Skin Test Results:
False negative skin test results associated with anaphylaxis from subsequent exposure to the allergen have been reported during postmarketing diagnostic use of some food allergenic extracts. Based on the patient’s clinical history and the index of suspicion, healthcare providers should consider confirming negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.
- PRECAUTIONS
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INFORMATION FOR PATIENTS:
Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to testing. Also, see ADVERSE REACTIONS and WARNINGS Sections.
Patients should always be observed 20 to 30 minutes after testing.
General:
- In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications for skin testing must be weighed carefully against the risk of temporarily aggravating the symptoms by the testing itself. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration and prior to discharge may be useful in unstable asthmatics to reduce the chances of exacerbation of the patient’s asthma. Patients should be instructed to describe any active allergic symptoms as described above prior to skin testing and encouraged to report any late reactions from this testing. Also, see ADVERSE REACTIONS and WARNING sections.
- Store allergenic extracts between 2°-8°C at all times, even during use.
- Care must be taken to avoid drawing blood.
- For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
- For intradermal skin testing, pull gently on the syringe plunger and note if any blood enters the syringe. If blood is obtained, reposition the needle and repeat before injecting (see DOSAGE AND ADMINISTRATION).
- For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
- Allergenic extracts become less potent with age. Allergenic extracts containing glycerin 50% v/v are relatively stable. Non-glycerinated aqueous extracts, particularly dilute forms as used for intradermal skin testing, have been shown to be extremely unstable. Until such time as stability studies are complete with dilute allergens, new intradermal strength materials should be prepared every few weeks.
- Use standard aseptic precautions if making dilutions from stock concentrates to intradermal strength.
- For intradermal testing: Extracts in glycerin 50% v/v must be diluted with a non-glycerinated diluent and must be diluted at least 25-fold to less than 2% glycerin by volume, as glycerin above this level can cause false positive intradermal skin test results.
Pregnancy - Category C:
Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother4. However, on the basis of histamine’s known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure to skin test overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman and only if clearly needed.
Pediatric Use:
Allergenic extracts for diagnostic use have been given safely in infants and young children. Infants have lower skin test reactivity to histamine, as well as common allergens. Skin test reactivity gradually increases to age 6 and plateaus to age 60. Therefore, small skin test reactions should be anticipated in children under age 6.
Geriatric Use:
Skin test reactivity gradually decreases after age 60. Therefore, smaller skin test reactions should be anticipated in adults over age 60.
Nursing Mothers:
It is not known if allergens administered subcutaneously appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
Drug Interactions:
Drugs can interfere with the performance of skin tests5.
Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine) and can be as long as 40 days (astemizole).
Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks.
Beta2 Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.
Dopamine: Intravenous infusion of dopamine may inhibit skin test responses.
Beta Blocking Agents: Propranolol can significantly increase skin test reactivity.
Other Drugs: Short acting steroids, inhaled beta2 agonists, theophylline and cromolyn do not seem to affect skin test response.
- In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications for skin testing must be weighed carefully against the risk of temporarily aggravating the symptoms by the testing itself. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration and prior to discharge may be useful in unstable asthmatics to reduce the chances of exacerbation of the patient’s asthma. Patients should be instructed to describe any active allergic symptoms as described above prior to skin testing and encouraged to report any late reactions from this testing. Also, see ADVERSE REACTIONS and WARNING sections.
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ADVERSE REACTIONS
Fatalities from skin testing in the United States have been extensively reviewed by Lockey.2 Six fatalities were associated with intradermal testing without previous percutaneous testing, and one was associated with a combination of percutaneous (scratch) and intradermal skin testing. With careful attention to dosage and administration, fatal reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and overdosage could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts for skin testing understand, and be prepared for the treatment of severe reactions.
Local:
Immediate wheal and erythema reactions are to be expected; but if very large, may be the first manifestation of a systemic reaction. In such cases, immediately wipe the test site(s) with sterile gauze or cotton to remove excess allergen.
Systemic Reactions:
Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching (other than at the skin test site), extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope, and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20 - 30 minutes after testing.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction unresponsive to bronchodilator may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration of 0.2 mL to 1.0 mL of epinephrine injection (1:1,000) is recommended. Maximum recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes.
Adverse events should be reported via MedWatch (1-800-FDA-1088), Adverse Event Reporting, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.
- OVERDOSAGE
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DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Skin test techniques for immediate (Type I) hypersensitivity testing fall into two major categories: percutaneous, and intracutaneous.
Percutaneous techniques:
For percutaneous testing, in general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen. There are several devices available for this technique. Refer to the manufacturer or distributor’s circular for specific directions for their use.
In General:
- It is recommended that the test areas should be placed no closer than 4 - 5 cm apart to avoid interference of reactions when several tests are applied.
- Skin test areas should be cleansed with alcohol and air dried.
- Preferably, the allergen should be placed on the volar surface of the forearm, upper arm, or the patient’s back. The patient should be placed in a comfortable position prior to testing.
- For scratch testing, a sharp, clean, sterile instrument is used to abrade the skin, but not to draw blood. Each scratch should be about 2 - 4 mm in length. A small drop of extract is placed on the surface of the skin.
- Prick testing: For prick testing, a sharp, sterile instrument is used to puncture the skin slightly, applying it at a 15 - 20° angle to the skin. The instrument is gently raised, “tenting” the skin until it pops out, generally pricking through the drop of allergen. Do not draw blood.
- For puncture testing, a sharp, clean, sterile instrument must be used. Puncture the skin, through the drop of allergen, perpendicular to the skin. Do not draw blood.
For all of the above techniques, a separate instrument must be used for each patient; if the instrument is to be used to pass through the allergen, to avoid cross-contamination, a separate instrument is to be used for each allergen. The test should be read in 15 minutes, measuring both wheal size and erythema.
Intracutaneous (intradermal) testing:
General: Intradermal testing is more sensitive than percutaneous testing and its specificity is dependent on dose. Intradermal testing is not intended as an initial screen unless used in highly dilute solutions. Intradermal testing is usually reserved for allergens that have demonstrated either negative or equivocal percutaneous skin test response in the face of positive or unclear history.
Intradermal testing of one allergen in several serial dilutions (beginning with the weakest to the more concentrated dilutions) may also be useful in assessing degree of patient sensitivity for the establishment of a safe starting dose for immunotherapy.
Bulk extracts must be diluted for intradermal testing. Use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of diluent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration. As a general rule intradermal strength should begin at no higher than 1/100 to 1/1000 of the percutaneous strength that resulted in a negative skin test reaction.
- It is recommended that the test areas should be spaced no less than 5 cm apart to avoid interference with adjacent allergen or control.
- Skin should be cleansed with alcohol and air dried.
- A sterile 1 mL or 1/2 mL syringe with a 26 - 30 gauge needle should be used. A separate sterile syringe should be used for each extract and each patient.
- Care should be taken to eliminate air bubbles from the syringe prior to injecting the test dose. It is suggested that not more than 6 - 10 allergens of each different type be used at any one time. Very sensitive patients may show rapid response.
- The skin is held tensely, and the needle is inserted almost parallel to the skin, beveled side up far enough to cover the beveled portion. Slowly inject sufficient extract to make a small bleb of approximately 5 mm in diameter (0.01 - 0.02 mL).
- Read the test results in 15 minutes.
Selection of the proper strength for intracutaneous testing: A general rule for the prevention of untoward reactions, particularly in extremely sensitive patients, is to screen by percutaneous methods initially, and begin intradermal testing at a strength not more than 1/100 of a negative or equivocal percutaneous reaction.
Controls:
In both percutaneous and intracutaneous tests, a negative control test with diluent alone should be performed because some patients exhibit dermographia, and/or other non-specific irritant responses.
As a positive control in the evaluation of allergenic skin testing, histamine 1 mg/mL (histamine base) should be used for percutaneous testing, and histamine 0.1 mg/mL (histamine base) should be used for intradermal testing.
Interpretation of results:
Patient’s response is graded on the basis of the size of erythema or wheal.6 General guidelines follow for percutaneous testing, different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer’s or distributor’s instructions when grading reactions.
Percutaneous (prick or scratch) test:
0 No reaction or less than control.
+ Erythema greater than control, smaller than a nickel (21 mm diameter).
++ Erythema greater than a nickel in diameter, no wheal.
+++ Wheal and erythema without pseudopods.
++++ Wheal and erythema with pseudopods.
Intradermal test:
0 No reaction or less than negative control.
+ 3-4 mm wheal with erythema, or erythema alone larger than a nickel (21 mm diameter).
++ 4-8 mm wheal and erythema, without pseudopods.
+++ Over 8 mm wheal and erythema without pseudopods.
++++ Wheal and erythema with pseudopods.
- It is recommended that the test areas should be placed no closer than 4 - 5 cm apart to avoid interference of reactions when several tests are applied.
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HOW SUPPLIED
For scratch and prick testing: 5 mL dropper applicator vials in 50% v/v glycerin or 10mL stoppered vial in 50% v/v glycerin. Available individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).
For intracutaneous testing: 5 mL sterile vials, aqueous based, individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).
Histatrol® Positive skin test control - histamine. 1 mg/mL and 0.1 mg/mL histamine base.
See Product Catalog for specific diagnostic concentrations available.
- STORAGE
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REFERENCES
- Holgate, S.T., Robinson, C. and Church, M.K. Mediators of immediate hypersensitivity. In Middleton et al: Allergy Principles and Practice, St. Louis, 1988, C.V. Mosby, p 135.
- Lockey, R.F., et al. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 1987: 79: 660.
- Reid, M.J. et al. Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin Immunol. 1993; 92:6.
- DeBuske L. M. et al. Special problems regarding Allergen Immunotherapy in Immunology and Allergy Clinics of North America, Greenburger, P.A. Ed. February 1992; 145-149.
- Bousquet, J. In vivo methods for the study of allergy: skin test, techniques and interpretation. In: Middleton et al.: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
- Freedman, S.O. Asthma and Allergic Rhinitis II. Clinical Aspects, in Freedman and Gold Clinical Immunology 2nd Ed. New York: Harper & Row, 1976: 131.
Revised February 2023 No. 112S
© ALK-Abelló, Inc.
Distributed in Canada by:
ALK-Abelló Pharmaceuticals, Inc.
#35-151 Brunel Road
Mississauga, Ontario
Canada L4Z 2H6 - Holgate, S.T., Robinson, C. and Church, M.K. Mediators of immediate hypersensitivity. In Middleton et al: Allergy Principles and Practice, St. Louis, 1988, C.V. Mosby, p 135.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALMOND
prunus dulcis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6100 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6100-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6100-10 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 BLA103753 02/23/1998 APPLE
malus domestica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6101 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6101-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6101-10 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 BLA103753 02/23/1998 APRICOT
prunus armeniaca injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6102 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APRICOT (UNII: 269CJD5GZ9) (APRICOT - UNII:269CJD5GZ9) APRICOT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6102-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 ASPARAGUS
asparagus officinalis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6103 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPARAGUS (UNII: Z1EJP3037Z) (ASPARAGUS - UNII:Z1EJP3037Z) ASPARAGUS 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6103-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 AVOCADO
persea americana injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6104 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOCADO (UNII: SDS87L369F) (AVOCADO - UNII:SDS87L369F) AVOCADO 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6104-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6104-10 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 BLA103753 02/23/1998 BANANA
musa sapientum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6105 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6105-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6105-10 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 BLA103753 02/23/1998 BARLEY
hordeum vulgare injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6106 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6106-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6106-10 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 BLA103753 02/23/1998 BEEF
bos taurus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6109 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6109-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6109-10 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 BLA103753 02/23/1998 BELL PEPPER
capsicum annuum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6197 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GREEN BELL PEPPER (UNII: 4J4DOU3HEK) (GREEN BELL PEPPER - UNII:4J4DOU3HEK) GREEN BELL PEPPER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6197-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 BLACK PEPPER
piper nigrum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6198 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6198-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6198-10 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 BLA103753 02/23/1998 BRAZIL NUT
bertholletia excelsa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6110 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6110-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6110-10 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 BLA103753 02/23/1998 BROCCOLI
brassica oleracea var. botrytis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6112 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROCCOLI (UNII: UOI4FT57BZ) (BROCCOLI - UNII:UOI4FT57BZ) BROCCOLI 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6112-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 BUCKWHEAT
fagopyrum esculentum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6113 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUCKWHEAT (UNII: N0Y68724R3) (BUCKWHEAT - UNII:N0Y68724R3) BUCKWHEAT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6113-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6113-10 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 BLA103753 02/23/1998 CABBAGE
brassica oleracea var. capitata injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6114 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CABBAGE (UNII: GW0W1Y9I97) (CABBAGE - UNII:GW0W1Y9I97) CABBAGE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6114-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 CANTALOUPE
cucumis melo cantalupensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6115 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6115-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6115-10 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 BLA103753 02/23/1998 CARROT
daucus carota injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6116 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6116-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6116-10 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 BLA103753 02/23/1998 CASEIN
bos taurus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6118 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6118-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6118-10 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 BLA103753 02/23/1998 CELERY
apium graveolens injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6120 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6120-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6120-10 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 BLA103753 02/23/1998 CHERRY
prunus avium injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6121 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SWEET CHERRY (UNII: 93T4562ZI3) (SWEET CHERRY - UNII:93T4562ZI3) SWEET CHERRY 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6121-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6121-10 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 BLA103753 02/23/1998 CHICKEN MEAT
gallus gallus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6122 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6122-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6122-10 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 BLA103753 02/23/1998 CINNAMON
cinnamomum verum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6123 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6123-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6123-10 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 BLA103753 02/23/1998 CLAM
mercenaria mercenaria injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6124 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORTHERN QUAHOG (UNII: D6G49OV9IM) (NORTHERN QUAHOG - UNII:D6G49OV9IM) NORTHERN QUAHOG 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6124-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6124-10 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 BLA103753 02/23/1998 COCOA BEAN
theobroma cacao injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6125 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA (UNII: D9108TZ9KG) (COCOA - UNII:D9108TZ9KG) COCOA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6125-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6125-10 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 BLA103753 02/23/1998 COCONUT
cocos nucifera injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6127 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6127-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6127-10 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 BLA103753 02/23/1998 CODFISH
gadus morhua injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6128 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6128-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6128-10 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 BLA103753 02/23/1998 COFFEE
coffee arabica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6129 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6129-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6129-10 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 BLA103753 02/23/1998 COWS MILK
bos taurus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6178 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6178-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6178-10 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 BLA103753 02/23/1998 CRAB
paralithodes camtschaticus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6130 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RED KING CRAB (UNII: E88KKF623O) (RED KING CRAB - UNII:E88KKF623O) RED KING CRAB 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6130-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6130-10 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 BLA103753 02/23/1998 CUCUMBER
cucumis sativus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6132 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUCUMBER (UNII: YY7C30VXJT) (CUCUMBER - UNII:YY7C30VXJT) CUCUMBER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6132-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 EGG WHITE
gallus gallus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6133 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE (UNII: 3E0I92Z2GR) (EGG WHITE - UNII:3E0I92Z2GR) EGG WHITE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6133-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6133-10 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 BLA103753 02/23/1998 EGG YOLK
gallus gallus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6136 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK (UNII: 4IPS17B70T) (EGG YOLK - UNII:4IPS17B70T) EGG YOLK 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6136-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6136-10 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 BLA103753 02/23/1998 EGG, WHOLE
gallus gallus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6135 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6135-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6135-10 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 BLA103753 02/23/1998 ENGLISH WALNUT
juglans regia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6231 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6231-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6231-10 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 BLA103753 02/23/1998 FLOUNDER
paralichthys dentatus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6137 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMMER FLOUNDER (UNII: 50A63WC635) (SUMMER FLOUNDER - UNII:50A63WC635) SUMMER FLOUNDER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6137-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 GARLIC
allium sativum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6138 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6138-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6138-10 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 BLA103753 02/23/1998 GOATS MILK
capra aegagrus hircus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6177 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOAT MILK (UNII: XE5K5I4RP7) (GOAT MILK - UNII:XE5K5I4RP7) GOAT MILK 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6177-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 GRAPEFRUIT
citrus x paradisi injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6141 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRAPEFRUIT (UNII: O82C39RR8C) (GRAPEFRUIT - UNII:O82C39RR8C) GRAPEFRUIT 0.10 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6141-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 GREEN PEA
pisum sativum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6191 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6191-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6191-10 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 BLA103753 02/23/1998 HALIBUT
hippoglossus hippoglossus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-7130 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC HALIBUT (UNII: 7E34E106BO) (ATLANTIC HALIBUT - UNII:7E34E106BO) ATLANTIC HALIBUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-7130-06 5 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 BLA103753 01/01/1965 HALIBUT
atlantic halibut injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6236 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC HALIBUT (UNII: 7E34E106BO) (ATLANTIC HALIBUT - UNII:7E34E106BO) ATLANTIC HALIBUT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6236-10 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 BLA103753 01/01/1965 05/10/2023 HONEYDEW
cucumis melo injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6146 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HONEYDEW MELON (UNII: RN8P45F92A) (HONEYDEW MELON - UNII:RN8P45F92A) HONEYDEW MELON 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6146-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 KIDNEY BEAN
phaseolus vulgaris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6107 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6107-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6107-10 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 BLA103753 02/23/1998 LAMB
ovis aries injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6149 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6149-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6149-10 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 BLA103753 02/23/1998 LEMON
citrus limon injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6170 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEMON (UNII: 24RS0A988O) (LEMON - UNII:24RS0A988O) LEMON 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6170-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 LETTUCE
lactuca sativa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6171 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LETTUCE (UNII: 5PO6NN3RRJ) (LETTUCE - UNII:5PO6NN3RRJ) LETTUCE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6171-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6171-10 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 BLA103753 02/23/1998 LIMA BEAN
phaseolus lunatus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6173 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIMA BEAN (UNII: 112YH1ZMX2) (LIMA BEAN - UNII:112YH1ZMX2) LIMA BEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6173-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 LOBSTER
homarus americanus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6174 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMERICAN LOBSTER (UNII: 6T362S6JF6) (AMERICAN LOBSTER - UNII:6T362S6JF6) AMERICAN LOBSTER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6174-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6174-10 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 BLA103753 02/23/1998 MIXED FISH
paralichthys dentatus, gadus morhua, hippoglossus hippoglossus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8043 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC HALIBUT (UNII: 7E34E106BO) (ATLANTIC HALIBUT - UNII:7E34E106BO) ATLANTIC HALIBUT 0.1 g in 1 mL ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD 0.1 g in 1 mL SUMMER FLOUNDER (UNII: 50A63WC635) (SUMMER FLOUNDER - UNII:50A63WC635) SUMMER FLOUNDER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-8043-06 5 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 BLA103753 01/01/1965 MIXED FISH
paralichthys dentatus, gadus morhua, hippoglossus hippoglossus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8044 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC HALIBUT (UNII: 7E34E106BO) (ATLANTIC HALIBUT - UNII:7E34E106BO) ATLANTIC HALIBUT 0.1 g in 1 mL ATLANTIC COD (UNII: RPX7J99EXW) (ATLANTIC COD - UNII:RPX7J99EXW) ATLANTIC COD 0.1 g in 1 mL SUMMER FLOUNDER (UNII: 50A63WC635) (SUMMER FLOUNDER - UNII:50A63WC635) SUMMER FLOUNDER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-8044-10 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 BLA103753 01/01/1965 MIXED SHELLFISH
paralithodes camtschaticus, crangon crangon, homarus americanus, crassostrea virginica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8061 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RED KING CRAB (UNII: E88KKF623O) (RED KING CRAB - UNII:E88KKF623O) RED KING CRAB 0.1 g in 1 mL COMMON SHRIMP (UNII: 1U601HV1HW) (COMMON SHRIMP - UNII:1U601HV1HW) COMMON SHRIMP 0.1 g in 1 mL AMERICAN LOBSTER (UNII: 6T362S6JF6) (AMERICAN LOBSTER - UNII:6T362S6JF6) AMERICAN LOBSTER 0.1 g in 1 mL EASTERN OYSTER (UNII: 0I77C68AWS) (EASTERN OYSTER - UNII:0I77C68AWS) EASTERN OYSTER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-8061-06 5 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 BLA103753 02/23/1998 MIXED SHELLFISH
paralithodes camtschaticus, crangon crangon, homarus americanus, crassostrea virginica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8062 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RED KING CRAB (UNII: E88KKF623O) (RED KING CRAB - UNII:E88KKF623O) RED KING CRAB 0.1 g in 1 mL COMMON SHRIMP (UNII: 1U601HV1HW) (COMMON SHRIMP - UNII:1U601HV1HW) COMMON SHRIMP 0.1 g in 1 mL AMERICAN LOBSTER (UNII: 6T362S6JF6) (AMERICAN LOBSTER - UNII:6T362S6JF6) AMERICAN LOBSTER 0.1 g in 1 mL EASTERN OYSTER (UNII: 0I77C68AWS) (EASTERN OYSTER - UNII:0I77C68AWS) EASTERN OYSTER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-8062-10 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 BLA103753 02/23/1998 MUSHROOM
agaricus campestris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6180 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CULTIVATED MUSHROOM (UNII: 54C8E6W6JY) (CULTIVATED MUSHROOM - UNII:54C8E6W6JY) CULTIVATED MUSHROOM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6180-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6180-10 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 BLA103753 02/23/1998 MUSTARD
sinapis alba injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6181 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHITE MUSTARD SEED (UNII: 25VR943RPP) (WHITE MUSTARD SEED - UNII:25VR943RPP) WHITE MUSTARD SEED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6181-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6181-10 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 BLA103753 02/23/1998 OAT GRAIN
avena sativa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6183 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) (AVENA SATIVA WHOLE - UNII:5P8D0Z74RG) AVENA SATIVA WHOLE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6183-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6183-10 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 BLA103753 02/23/1998 OLIVE
olea europaea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6185 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK OLIVE (UNII: 2M6QWV94OC) (BLACK OLIVE - UNII:2M6QWV94OC) BLACK OLIVE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6185-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 ONION
allium cepa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6186 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6186-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6186-10 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 BLA103753 02/23/1998 ORANGE
citrus x sinensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6187 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6187-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6187-10 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 BLA103753 02/23/1998 OYSTER
crassostrea virginica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6189 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EASTERN OYSTER (UNII: 0I77C68AWS) (EASTERN OYSTER - UNII:0I77C68AWS) EASTERN OYSTER 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6189-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6189-10 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 BLA103753 02/23/1998 PEACH
prunus persica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6192 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6192-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6192-10 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 BLA103753 02/23/1998 PEANUT
arachis hypogaea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6193 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6193-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6193-10 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 BLA103753 02/23/1998 PEAR
pyrus communis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6195 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEAR (UNII: 2ZN8DWC0YF) (PEAR - UNII:2ZN8DWC0YF) PEAR 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6195-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 PECAN NUT
carya illinoinensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6196 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6196-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6196-10 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 BLA103753 02/23/1998 PINEAPPLE
ananas comosus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6200 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINEAPPLE (UNII: 2A88ZO081O) (PINEAPPLE - UNII:2A88ZO081O) PINEAPPLE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6200-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6200-10 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 BLA103753 02/23/1998 PISTACHIO NUT
pistacia vera injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6202 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PISTACHIO (UNII: 6815CPT6ZJ) (PISTACHIO - UNII:6815CPT6ZJ) PISTACHIO 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6202-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6202-10 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 BLA103753 02/23/1998 PLUM
prunus domestica injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6203 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLUM (UNII: 67M3EQ6BE1) (PLUM - UNII:67M3EQ6BE1) PLUM 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6203-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 PORK
sus scrofa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6204 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6204-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6204-10 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 BLA103753 02/23/1998 RICE
oryza sativa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6208 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHITE RICE (UNII: A195V20H7A) (WHITE RICE - UNII:A195V20H7A) WHITE RICE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6208-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6208-10 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 BLA103753 02/23/1998 RYE GRAIN
secale cereale injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6210 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6210-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6210-10 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 BLA103753 02/23/1998 SALMON
salmo salar injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6212 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATLANTIC SALMON (UNII: 7062I37LB3) (ATLANTIC SALMON - UNII:7062I37LB3) ATLANTIC SALMON 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6212-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6212-10 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 BLA103753 02/23/1998 SESAME SEED
sesamum indicum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6213 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6213-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6213-10 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 BLA103753 02/23/1998 SHRIMP
crangon crangon injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6214 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COMMON SHRIMP (UNII: 1U601HV1HW) (COMMON SHRIMP - UNII:1U601HV1HW) COMMON SHRIMP 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6214-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6214-10 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 BLA103753 02/23/1998 SOYBEAN
glycine max injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6216 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6216-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6216-10 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 BLA103753 02/23/1998 SPINACH
spinacia oleracea injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6218 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPINACH (UNII: 6WO75C6WVB) (SPINACH - UNII:6WO75C6WVB) SPINACH 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6218-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 SQUASH
curcubita pepo injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6219 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZUCCHINI (UNII: EQU1BON34S) (ZUCCHINI - UNII:EQU1BON34S) ZUCCHINI 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6219-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 STRAWBERRY
fragaria x ananassa injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6220 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRAWBERRY (UNII: 4J2TY8Y81V) (STRAWBERRY - UNII:4J2TY8Y81V) STRAWBERRY 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6220-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6220-10 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 BLA103753 02/23/1998 STRINGBEAN
phaseolus vulgaris injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6108 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6108-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6108-10 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 BLA103753 02/23/1998 SWEET CORN
zea mays injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6221 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6221-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6221-10 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 BLA103753 02/23/1998 SWEET POTATO
ipomoea batatas injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6205 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SWEET POTATO (UNII: M9WGG9Z9GK) (SWEET POTATO - UNII:M9WGG9Z9GK) SWEET POTATO 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6205-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6205-10 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 BLA103753 02/23/1998 THEA SINENSIS
thea sinensis injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6235 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TEA LEAF (UNII: GH42T47V24) (TEA LEAF - UNII:GH42T47V24) TEA LEAF 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6235-06 5 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:0268-6235-10 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 BLA103753 02/23/1998 TOMATO
solanum lycopersicum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6224 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6224-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6224-10 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 BLA103753 02/23/1998 TUNA
thunnus thynnus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6226 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORTHERN BLUEFIN TUNA (UNII: 816CLQ4017) (NORTHERN BLUEFIN TUNA - UNII:816CLQ4017) NORTHERN BLUEFIN TUNA 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6226-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6226-10 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 BLA103753 02/23/1998 TURKEY
meleagris gallopavo injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6229 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TURKEY (UNII: 8E9NT44R8I) (TURKEY - UNII:8E9NT44R8I) TURKEY 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6229-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6229-10 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 BLA103753 02/23/1998 VANILLA
vanilla planifolia injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6230 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANILLA BEAN (UNII: Q74T35078H) (VANILLA BEAN - UNII:Q74T35078H) VANILLA BEAN 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6230-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 VITIS SPP
vitis spp injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6139 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRAPE (UNII: 6X543N684K) (GRAPE - UNII:6X543N684K) GRAPE 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6139-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6139-10 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 BLA103753 02/23/1998 WATERMELON
citrullus lanatus injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6233 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATERMELON (UNII: 231473QB6R) (WATERMELON - UNII:231473QB6R) WATERMELON 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6233-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998 WHEAT GRAIN
triticum aestivum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6234 Route of Administration PERCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 0.1 g in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM METABISULFITE (UNII: 4VON5FNS3C) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6234-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6234-10 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 BLA103753 02/23/1998 WHITE POTATO
solanum tuberosum injection, solutionProduct Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-6206 Route of Administration PERCUTANEOUS 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOL (UNII: 339NCG44TV) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6206-06 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-6206-10 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 BLA103753 02/23/1998 Labeler - ALK-Abello, Inc. (809998847)