ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER  - equus caballus hair and equus caballus dander injection, solution 
ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER  - bos taurus hair and bos taurus dander injection, solution 
ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP  - canis lupus familiaris hair and canis lupus familiaris dander injection, solution 
ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.  - canis lupus familiaris hair and canis lupus familiaris dander injection, solution 
ANIMAL ALLERGENS, FEATHER MIX  - gallus gallus feather, anas platyrhynchos feather and anser anser feather injection, solution 
ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER  - cavia porcellus hair and cavia porcellus dander injection, solution 
AP HOUSE DUST MIX  - house dust injection, solution 
DUST, HOUSE MIXTURE  - house dust injection, solution 
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP.  - beef injection, solution 
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT GALLUS SP.  - poultry injection, solution 
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, WHITE GALLUS SP.  - egg white injection, solution 
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, YOLK GALLUS SP.  - egg yolk injection, solution 
FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, PORK SUS SP.  - pork injection, solution 
FOOD - DAIRY PRODUCTS, CASEIN, COW MILK  - casein injection, solution 
FOOD - DAIRY PRODUCTS, MILK, WHOLE COW  - cow milk injection, solution 
FOOD - FISH AND SHELLFISH, CLAM  - clam injection, solution 
FOOD - FISH AND SHELLFISH, CODFISH GADUS CALLARIAS  - codfish injection, solution 
FOOD - FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI  - crab injection, solution 
FOOD - FISH AND SHELLFISH, LOBSTER HOMARUS AMERICANUS  - lobster injection, solution 
FOOD - FISH AND SHELLFISH, SALMON SALMO SALAR  - salmon injection, solution 
FOOD - FISH AND SHELLFISH, SHRIMP CRAGO SP.  - shrimp injection, solution 
FOOD - FISH AND SHELLFISH, TUNA THUNNUS SP.  - tuna injection, solution 
FOOD - PLANT SOURCE, ALMOND PRUNUS AMYGDALUS  - almond injection, solution 
FOOD - PLANT SOURCE, APPLE MALUS SP.  - apple injection, solution 
FOOD - PLANT SOURCE, BANANA MUSA SAPIENTUM  - banana injection, solution 
FOOD - PLANT SOURCE, BRAZIL NUT BERTHOLLETIA EXCELSA  - brazil nut injection, solution 
FOOD - PLANT SOURCE, CARROT DAUCUS CAROTA  - carrot injection, solution 
FOOD - PLANT SOURCE, CASHEW NUT ANACARDIUM OCCIDENTALIE  - cashew injection, solution 
FOOD - PLANT SOURCE, CELERY APIUM GRAVEOLENS  - celery injection, solution 
FOOD - PLANT SOURCE, CORN ZEA MAYS  - corn injection, solution 
FOOD - PLANT SOURCE, HAZELNUT (FILBERT) CORYLUS SPP.  - hazelnut injection, solution 
FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO  - cantaloupe injection, solution 
FOOD - PLANT SOURCE, ORANGE CITRUS SINENSIS  - orange injection, solution 
FOOD - PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM  - pea injection, solution 
FOOD - PLANT SOURCE, PEACH PRUNUS PERSICA  - peach injection, solution 
FOOD - PLANT SOURCE, PEANUT ARACHIS HYPOGAEA  - peanut injection, solution 
FOOD - PLANT SOURCE, PECAN CARYA ILLINOENSIS  - pecan injection, solution 
FOOD - PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM  - potato injection, solution 
FOOD - PLANT SOURCE, RICE, WHOLE GRAIN  - rice injection, solution 
FOOD - PLANT SOURCE, RYE GRAIN  - rye injection, solution 
FOOD - PLANT SOURCE, SOYBEAN GLYCINE SOJA  - soybean injection, solution 
FOOD - PLANT SOURCE, STRAWBERRY FRAGARIA CHILOENSIS  - strawberry injection, solution 
FOOD - PLANT SOURCE, STRING BEAN MIX  - string bean injection, solution 
FOOD - PLANT SOURCE, TOMATO NICOTIANA SPP.  - tomato injection, solution 
FOOD - PLANT SOURCE, WALNUT, BLACK JUGLANS NIGRA  - black walnut injection, solution 
FOOD - PLANT SOURCE, YEAST, BAKER SACCHAROMYCES CEREVISIAE  - yeast injection, solution 
FOOD - PLANT SOURCE, YEAST, BREWER SACCHAROMYCES CEREVISIAE  - yeast injection, solution 
INSECTS (WHOLE BODY) COCKROACH MIX  - periplaneta americana and blatella germanica injection, solution 
INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS INVICTA  - solenopsis invicta injection, solution 
INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS RICHTERI  - solenopsis richteri injection, solution 
INSECTS (WHOLE BODY), FIRE ANT MIX  - solenopsis richteri and solenopsis invicta injection, solution 
MOLDS - ALTERNARIA/HORMODENDRUM MIX  - alternaria alternata and cladosporium cladosporioides injection, solution 
MOLDS - MOLD MIX 10  - alternaria alternata, aspergillus fumigatus, emericella nidulans, aspergillus niger var. niger, aspergillus terreus, fusarium oxysporum vasinfectum, dendryphiella vinosa, cladosporium cladosporioides, mucor racemosus, penicillium digitatum, penicillium expansum, penicillium expansum, penicillium chrysogenum var. chrysogenum, clonostachys rosea f. rosea, phoma exigua var. exigua, aureobasidium pullulans var. pullutans and rhizopus stolonifer injection, solution 
MOLDS - MOLD MIX 4  - alternaria alternata, aspergillus fumigatus, emericella nidulans, aspergillus niger var. niger, aspergillus terreus, cladosporium cladosporioides, penicillium digitatum, penicillium expansum, penicillium expansum, penicillium chrysogenum var. chrysogenum and clonostachys rosea f. rosea injection, solution 
MOLDS - TRICHOPHYTON MIX  - trichophyton tonsurans, trichophyton rubrum and trichophyton mentagrophytes injection, solution 
MOLDS, PENICILLIUM MIX  - penicillium digitatum, penicillium expansum, penicillium expansum, penicillium chrysogenum var. chrysogenum and clonostachys rosea f. rosea injection, solution 
MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS  - alternaria alternata injection, solution 
MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS  - aspergillus fumigatus injection, solution 
MOLDS, RUSTS AND SMUTS, ASPERGILLUS NIGER  - aspergillus niger var. niger injection, solution 
MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA  - botrytis cinerea injection, solution 
MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS  - candida albicans injection, solution 
MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM  - acremonium strictum injection, solution 
MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA  - cochliobolus spicifer injection, solution 
MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM  - epicoccum nigrum injection, solution 
MOLDS, RUSTS AND SMUTS, EPIDERMOPHYTON FLOCCOSUM  - epidermophyton floccosum injection, solution 
MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM  - fusarium oxysporum vasinfectum injection, solution 
MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM  - dendryphiella vinosa injection, solution 
MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES   - cladosporium cladosporioides injection, solution 
MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS  - mucor racemosus injection, solution 
MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM  - penicillium chrysogenum var. chrysogenum injection, solution 
MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM  - phoma exigua var. exigua injection, solution 
MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS  - aureobasidium pullulans var. pullutans injection, solution 
MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS  - rhizopus stolonifer injection, solution 
MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM  - pleospora tarda injection, solution 
POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM  - paspalum notatum pollen injection, solution 
POLLENS - GRASSES, BROME, SMOOTH BROMUS INERMIS  - bromus inermis pollen injection, solution 
POLLENS - GRASSES, CORN, CULTIVATED ZEA MAYS  - zea mays pollen injection, solution 
POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE  - sorghum halepense pollen injection, solution 
POLLENS - GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA  - avena sativa pollen injection, solution 
POLLENS - GRASSES, SOUTHERN GRASS MIX   - poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen, phleum pratense pollen, anthoxanthum odoratum pollen, sorghum halepense pollen and cynodon dactylon pollen injection, solution 
POLLENS - TREES, ACACIA ACACIA LONGIFOLIA  - acacia longifolia pollen injection, solution 
POLLENS - TREES, ALDER, RED ALNUS RUBRA  - alnus rubra pollen injection, solution 
POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA  - fraxinus americana pollen injection, solution 
POLLENS - TREES, BEECH, AMERICAN FAGUS GRANDIFOLIA  - fagus grandifolia pollen injection, solution 
POLLENS - TREES, BIRCH MIX   - betula papyrifera pollen, betula pendula pollen and betula nigra pollen injection, solution 
POLLENS - TREES, BOXELDER/MAPLE MIX  - acer negundo pollen, acer saccharum pollen and acer rubrum pollen injection, solution 
POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI  - juniperus ashei pollen injection, solution 
POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA  - juniperus virginiana pollen injection, solution 
POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES  - populus deltoides pollen injection, solution 
POLLENS - TREES, CYPRESS, ARIZONA CUPRESSUS ARIZONICA  - cupressus arizonica pollen injection, solution 
POLLENS - TREES, CYPRESS, BALD TAXODIUM DISTICHUM  - taxodium distichum pollen injection, solution 
POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA  - ulmus americana pollen injection, solution 
POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA  - ulmus parvifolia pollen injection, solution 
POLLENS - TREES, EUCALYPTUS (BLUE GUM) EUCALYPTUS GLOBULUS  - eucalyptus globulus pollen injection, solution 
POLLENS - TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA  - liquidambar styraciflua pollen injection, solution 
POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS  - celtis occidentalis pollen injection, solution 
POLLENS - TREES, HICKORY, SHAGBARK CARYA OVATA  - carya ovata pollen injection, solution 
POLLENS - TREES, LINDEN (BASSWOOD) TILIA AMERICANA  - tilia americana pollen injection, solution 
POLLENS - TREES, MAPLE, HARD ACER SACCHARUM  - acer saccharum pollen injection, solution 
POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA  - prosopis juliflora pollen injection, solution 
POLLENS - TREES, MULBERRY MIX  - morus alba pollen and morus rubra pollen injection, solution 
POLLENS - TREES, OAK MIX  - quercus rubra pollen, quercus virginiana pollen and quercus alba pollen injection, solution 
POLLENS - TREES, OAK, RED QUERCUS RUBRA  - quercus rubra pollen injection, solution 
POLLENS - TREES, OLIVE OLEA EUROPAEA  - olea europaea pollen injection, solution 
POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS  - carya illinoinensis pollen injection, solution 
POLLENS - TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE  - schinus molle pollen injection, solution 
POLLENS - TREES, PINE MIX  - pinus contorta pollen and pinus ponderosa pollen injection, solution 
POLLENS - TREES, PRIVET LIGUSTRUM VULGARE  - ligustrum vulgare pollen injection, solution 
POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA  - elaeagnus angustifolia pollen injection, solution 
POLLENS - TREES, SYCAMORE, AMERICAN (EASTERN) PLATANUS OCCIDENTALLIS  - platanus occidentalis pollen injection, solution 
POLLENS - TREES, TREE MIX 11  - fraxinus americana pollen, fagus grandifolia pollen, betula nigra pollen, juglans nigra pollen, populus deltoides pollen, ulmus americana pollen, carya ovata pollen, acer saccharum pollen, quercus rubra pollen, platanus occidentalis pollen and salix nigra pollen injection, solution 
POLLENS - TREES, TREE MIX 5  - carya illinoinensis pollen, acer saccharum pollen, acer negundo pollen, acer rubrum pollen, quercus rubra pollen, quercus virginiana pollen, quercus alba pollen, platanus occidentalis pollen and salix nigra pollen injection, solution 
POLLENS - TREES, TREE MIX 6  - fraxinus americana pollen, fagus grandifolia pollen, betula papyrifera pollen, betula nigra pollen, betula pendula pollen, juglans nigra pollen, populus deltoides pollen and ulmus americana pollen injection, solution 
POLLENS - TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA  - ailanthus altissima pollen injection, solution 
POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA  - juglans nigra pollen injection, solution 
POLLENS - TREES, WILLOW, BLACK SALIX NIGRA  - salix nigra pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM  - xanthium strumarium pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS  - solidago canadensis pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, LAMB QUARTERS CHENOPODIUM ALBUM  - chenopodium album pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, NETTLE URTICA DIOICA  - urtica dioica pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS  - amaranthus retroflexus pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA  - plantago lanceolata pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA  - ambrosia trifida pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA  - ambrosia psilostachya pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI  - salsola kali pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS  - artemisia vulgaris pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING (SHAD) ATRIPLEX CANESCENS  - atriplex canescens pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS  - cytisus scoparius injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA  - rumex acetosella pollen injection, solution 
POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI  - amaranthus palmeri pollen injection, solution 
POLLENS - WEEDS, CARELESS/PIGWEED MIX  - amaranthus palmeri pollen and amaranthus retroflexus pollen injection, solution 
POLLENS - WEEDS, DOCK/SORREL MIX  - rumex crispus pollen and rumex acetosella pollen injection, solution 
POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX  - ambrosia trifida pollen, ambrosia artemisiifolia pollen and ambrosia psilostachya pollen injection, solution 
POLLENS - WEEDS, KOCHIA SCOPARIA  - kochia scoparia pollen injection, solution 
POLLENS - WEEDS, MARSHELDER/POVERTY MIX  - iva axillaris pollen, iva annua var. annua pollen and iva xanthifolia pollen injection, solution 
POLLENS - WEEDS, WEED MIX 2630  - xanthium strumarium pollen, chenopodium album pollen, amaranthus retroflexus pollen, rumex crispus pollen and rumex acetosella pollen injection, solution 
Hollister-Stier Laboratories LLC

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INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING

DESCRIPTION

Sterile extracts for scratch, prick or puncture testing are supplied in dropper vials containing, in addition to the extract allergens and antigens, 50% (v/v) glycerin as preservative, 0.5% sodium chloride and 0.275% sodium bicarbonate. The strength of these extracts may be expressed in terms of

1. Weight to Volume (w/v)
2. Protein Nitrogen Units/mL (PNU/mL)
3. Allergy Units/mL (AU/mL)
4. Bioequivalent Allergy Units/mL (BAU/mL)
5. Concentrate
   

1. Weight to volume (w/v).
For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry, allergenically active concentrates produced by precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.

2. Protein Nitrogen Units per mL (PNU/mL).
One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, the PNU content of extracts from different manufacturers is not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.

3. Allergy Units per mL (AU/mL).
The potency of extracts labeled in Allergy Units per mL (AU/mL) is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA).

4. Bioequivalent Allergy Units per mL (BAU/mL).
When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 13 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature is being changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and such products will be labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.

5. Concentrate.
Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.

CLINICAL PHARMACOLOGY

Allergenic extracts for scratch, prick or puncture testing, used according to the DOSAGE AND ADMINISTRATION section, produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with reaction of antigen with IgE on the surface of basophils or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type "wheal and flare" skin reaction.

INDICATIONS & USAGE

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established. 14
In addition to a carefully taken history, the use of glycerin-containing extracts in scratch, prick or puncture testing is an accepted method in the diagnosis of allergic conditions. 1, 2, 3 Extracts of all allergens do not produce equivalent results in scratch, prick or puncture tests. The intensity of the skin reactions produced will be determined by two factors: the degree of sensitivity of the patient, and the nature of the allergenic extract applied.
Scratch, prick or puncture tests are not as sensitive as the intradermal test, but are safer and cause less discomfort. They may, therefore, be the method of choice when a large number of tests are needed, or when testing the pediatric patient. In some cases, where the relatively insensitive scratch, prick or puncture tests are negative or do not confirm the allergic history, follow-up intradermal tests may be positive. However, ANTIGENS PRODUCING LARGE 3 to 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

CONTRAINDICATIONS

There are no known absolute contraindications to allergy skin testing. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regimen.

WARNINGS

Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which s/he is sensitive. Use caution when skin testing patients during a season when pollen is present. Refer to boxed WARNINGS Section.

PRECAUTIONS

1. General

Always have injectable epinephrine and a tourniquet available when tests are being made. (See ADVERSE REACTION section.) Generally 50 to 60 scratch, prick or puncture tests can be applied safely at one sitting. Patients whose history suggests severe sensitivity should have only 5 to 10 tests applied at a time and these tests applied to the volar surface of one arm. These tests should not all be of the same type of antigen; that is, all grass pollens, all weed pollens, all danders, etc. One or two tests from several classes of antigens should be applied at a time. As soon as a large wheal begins to develop, wipe the antigen from it with a damp cotton sponge. After 10 minutes wipe off all the antigens with a damp cotton sponge, followed by a dry cotton sponge. Be careful not to wipe antigen from a positive reaction onto an adjacent test site.

2 Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.

3. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.9 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.9, 10 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.11 Topical local anesthetics may suppress the flare responses and should be
avoided in skin test sites.12

4. Carcinogenesis, mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

5. Pregnancy

4,5
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. Allergenic extracts should be given to a pregnant woman only if clearly needed.

6. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

7. Pediatric Use

Wheal sizes in response to allergen skin testing can be smaller in infants than in adults. The skin response to histamine parallels that for allergens; therefore, appropriate positive control skin tests should always be performed.1

8. Geriatric Use

Skin test wheal size decreases with age. The decrease in allergen-induced skin test reaction parallels that to histamine; therefore, appropriate positive skin test controls should always be performed.1

ADVERSE REACTIONS

1. Local Reactions
If a severe local reaction occurs during scratch, prick or puncture testing, WIPE OFF test antigen. Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8
It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, WIPE OFF test antigen, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1,000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

EPINEPHRINE:
ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and other appropriate drugs. Oxygen should be given by mask. Intravenous antihistamine, theophylline or corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures (Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986). Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.

OVERDOSAGE

See ADVERSE REACTIONS Section.

DOSAGE & ADMINISTRATION

1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2. Scratch, Prick or Puncture Testing Methods
There are two general methods of skin testing. (1) The skin is scarified first, and the extract is then applied. (2) A drop of extract is put onto the skin, and a prick or puncture is made through the drop. Avoid touching tip of dropper to skin. Either method is satisfactory, but the second requires that the instrument be cleansed between tests or that separate needles be used.

The extracts for scratch, prick or puncture testing are supplied in dropper vials and should be kept in a rack or box in rows of 10 vials corresponding to the rows of tests to be applied to the skin.

All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests (e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol). The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract.

Test sites should be examined at 15 and 30 minutes. To prevent excessive absorption, wipe off antigens producing large reactions as soon as the wheal appears. Record the size of the reaction. Delayed reactions may rarely occur from tests, so it may be helpful to examine the test sites in 24 hours.

Use of Scarifiers and Spacing. Make scarifications at least 2.5 cm apart. Use more space between pollen tests to prevent smearing into adjacent sites. Hold the scarifier between the thumb and index finger, press the sharp edge of the instrument against the skin and twirl instrument rapidly. The scratch should disrupt only the outer layers of epidermis but should not produce immediate oozing of blood. The amount of pressure needed to produce a satisfactory scratch will vary between patients according to the thickness or fragility of their skin. Experience will indicate the proper amount of pressure to exert in making the scratch. If the scarifier is kept sharp and the scratch made quickly, discomfort to the patient is minimized.

Use of Prick Test Needles. The skin is cleaned and single drops of each extract applied to the properly identified test sites. A small, sterile disposable needle, such as a 1/2-inch 26 gauge needle (with the bevel up), a bifurcated vaccinating needle, or a Prick Lancetter™ is inserted through the drop superficially into the skin, the skin lifted slightly and the needle withdrawn. No bleeding should be produced. After about 1 minute the extract may be wiped away.

3. Most Satisfactory Sites for Testing
Prior to testing, clean the skin area to be tested with ether or alcohol and allow to dry. Use a sterile instrument for each patient. The back or the volar surface of the arms are the most satisfactory sites for testing. Skin of the posterior thighs or abdomen may be used if necessary. Avoid very hairy areas where possible, since the reactions will be smaller and more difficult to interpret. The most satisfactory areas of the back are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas of the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anti-cubital space.

4. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction, it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

5. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient’s sensitivity to that allergen.

Standardized Products
(a) Mites:
The skin test concentration of 30,000 AU/mL in dropper vials is used for scratch, prick or puncture testing. Puncture tests performed on 12 highly sensitive subjects showed the following:

Species	Mean Sum of Wheal ± Std. Dev. (mm)	Mean Sum of Erythema ± Std. Dev. (mm)
D. farinae	22.4 ± 10.7	82.2 ± 21.7
D. pteronyssinus	24.0 ± 9.9	89.3 ± 24.5

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(b) Cat Hair and Cat Pelt: The skin test concentration of 10,000 BAU/mL (10-19.9 Fel d 1 Units/mL) in dropper vials is used for prick or puncture testing. Puncture tests performed on 15 highly sensitive subjects showed the following:

Product	Mean Sum of Wheal ± Std. Dev (mm)	Mean Sum of Erythema ± Std. Dev (mm)
Standardized Cat Hair	15.1 ± 3.8	73.3 ± 14.3
Standardized Cat Pelt	13.9 ± 4.3	67.3 ± 13.3

The sum of a skin response is the sum of the longest diameter and the mid-point orthogonal diameter.

(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: Short Ragweed extract at 1:20 w/v in 50% glycerin containing approximately 100 to 300 units of Antigen E/mL or Giant and Short Ragweed Mix at 1:20 w/v in 50% glycerin containing approximately 50 to 150 units of Antigen E/mL are usually used for scratch, prick or puncture testing.
Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

Grade	Erythema mm	Papule or Wheal mm	Corresponding mm ∑E
0	<5	<5	<10
±	5-10	5-10	10-20
1+	11-20	5-10	20-40
2+	21-30	5-10	40-60
3+	31-40	10-15 (a)	60-80
4+	>40	>15 (b)	>80

(a) or with pseudopods (b) or with many pseudopods

A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of the year, known exposures, and eating habits.
THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGIC HISTORY. THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

6. Geriatric Use

The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

7. Pediatric Use

The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

HOW SUPPLIED

In 5 mL dropper bottles of extract at 1:10 w/v excepting pollens at 1:20, AP™ extracts at 1:50 w/v, except AP™ Dog Hair-Dander at 1:100 w/v, AP™ House Dust at 20,000 PNU/mL, some mixes as Concentrate, and Standardized products at AU/mL (Mite extracts at 30,000 AU/mL) or BAU/mL (Cat Hair and Pelt extracts at 10,000 BAU/mL) value. Strengths are listed on product labels.

STORAGE

The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° to 8°C and kept at this temperature range during office use.

LIMITED WARRANTY

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCES

1. Middleton, Elliott, Jr., C.E. Reed and E.F. Ellis (Eds.) Allergy Principles and Practice. Fourth Edition, Vol. 1. C.V. Mosby. 1993.
2. Sheldon, J.M., R.G. Lovell and K.P. Mathews. A Manual of Clinical Allergy. W.B. Saunders. 1967.
3. Tuft, L. and H.L. Mueller. Allergy in Children. W.B. Saunders. 1970.
4. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy Clin. North Am. (USA). 12(1): 145-175, 1992.
5. Weinstein, A.M., B.D. Dubin, W.K. Podleski, S.L. Spector and R.S. Farr. Asthma and pregnancy. JAMA. 124(11): 1161-1165, 1979.
6. Jacobs, Robert L., Geoffrey W. Rake, Jr., et.al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127. August 1981.
7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987.
8. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
9. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
10. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79 (2): 345-349. February 1987.
11. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
12. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clin. Allergy. 17: 307-311, 1987.
13. Turkeltaub, Paul C., Suresh, C. Rastogi, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986.
14. Food and Drug Administration. Biological products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220): 59228ff. November 16, 1994.

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER  ap horse hair and dander   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4856 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Equus caballus hair (Equus caballus hair) Equus caballus hair 0.01 g  in 1 mL Equus caballus dander (Equus caballus dander) Equus caballus dander 0.01 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4856-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	01/30/1978

ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER  cattle hair and dander   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4812 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bos taurus hair (Bos taurus hair) Bos taurus hair 0.01 g  in 1 mL Bos taurus dander (Bos taurus dander) Bos taurus dander 0.01 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4812-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	01/30/1978

ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP  animal allergens, dog dander canis spp   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4825 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Canis lupus familiaris hair (Canis lupus familiaris hair) Canis lupus familiaris hair 0.005 g  in 1 mL Canis lupus familiaris dander (Canis lupus familiaris dander) Canis lupus familiaris dander 0.005 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4825-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	08/24/1976

ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP.  dog hair canis spp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4084 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Canis lupus familiaris hair (Canis lupus familiaris hair) Canis lupus familiaris hair 0.05 g  in 1 mL Canis lupus familiaris dander (Canis lupus familiaris dander) Canis lupus familiaris dander 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4084-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

ANIMAL ALLERGENS, FEATHER MIX  feather mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4350 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Gallus gallus Feather (Gallus gallus feather) Gallus gallus Feather 0.1 g  in 1 mL Anas platyrhynchos feather (Anas platyrhynchos feather) Anas platyrhynchos feather 0.1 g  in 1 mL Anser anser feather (Anser anser feather) Anser anser feather 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4350-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

ANIMAL ALLERGENS, GUINEA PIG HAIR AND DANDER  guinea pig hair and dander   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4402 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cavia porcellus hair (Cavia porcellus hair) Cavia porcellus hair 0.05 g  in 1 mL Cavia porcellus dander (Cavia porcellus dander) Cavia porcellus dander 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4402-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

AP HOUSE DUST MIX  ap house dust mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4705 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength House Dust (House Dust) House Dust 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4705-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	08/17/1972

DUST, HOUSE MIXTURE  dust, house mixture   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-4701 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength House Dust (House Dust) House Dust 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4701-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, BEEF BOVINE SPP.  beef bovine spp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3078 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Beef (Beef) Beef 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3078-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, CHICKEN MEAT GALLUS SP.  chicken meat gallus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3174 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Poultry (Poultry) Poultry 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3174-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, WHITE GALLUS SP.  egg, white gallus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3249 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Egg White (Egg White) Egg White 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3249-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, EGG, YOLK GALLUS SP.  egg, yolk gallus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3255 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Egg Yolk (Egg Yolk) Egg Yolk 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3255-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - ANIMAL PRODUCTS AND POULTRY PRODUCTS, PORK SUS SP.  pork sus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3510 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pork (Pork) Pork 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3510-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - DAIRY PRODUCTS, CASEIN, COW MILK  casein, cow milk   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3381 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Casein (Casein) Casein 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3381-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - DAIRY PRODUCTS, MILK, WHOLE COW  milk, whole cow   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3390 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cow Milk (Cow Milk) Cow Milk 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3390-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, CLAM  clam   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3192 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clam (Clam) Clam 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3192-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, CODFISH GADUS CALLARIAS  codfish gadus callarias   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3204 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Codfish (Codfish) Codfish 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3204-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI  crab xiphosurus sowerbyi   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3216 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Crab (Crab) Crab 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3216-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, LOBSTER HOMARUS AMERICANUS  lobster homarus americanus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3363 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lobster (Lobster) Lobster 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3363-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, SALMON SALMO SALAR  salmon salmo salar   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3564 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salmon (Salmon) Salmon 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3564-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, SHRIMP CRAGO SP.  shrimp crago sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3585 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Shrimp (Shrimp) Shrimp 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3585-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - FISH AND SHELLFISH, TUNA THUNNUS SP.  tuna thunnus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3675 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tuna (Tuna) Tuna 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3675-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, ALMOND PRUNUS AMYGDALUS  almond prunus amygdalus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3015 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Almond (Almond) Almond 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3015-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, APPLE MALUS SP.  apple malus sp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3021 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Apple (Apple) Apple 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3021-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, BANANA MUSA SAPIENTUM  banana musa sapientum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3042 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Banana (Banana) Banana 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3042-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, BRAZIL NUT BERTHOLLETIA EXCELSA  brazil nut bertholletia excelsa   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3108 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Brazil Nut (Brazil Nut) Brazil Nut 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3108-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, CARROT DAUCUS CAROTA  carrot daucus carota   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3126 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carrot (Carrot) Carrot 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3126-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, CASHEW NUT ANACARDIUM OCCIDENTALIE  cashew nut anacardium occidentalie   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3135 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cashew (Cashew) Cashew 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3135-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, CELERY APIUM GRAVEOLENS  celery apium graveolens   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3141 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Celery (Celery) Celery 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3141-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, CORN ZEA MAYS  corn zea mays   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3213 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Corn (Corn) Corn 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3213-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, HAZELNUT (FILBERT) CORYLUS SPP.  hazelnut (filbert) corylus spp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3306 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hazelnut (Hazelnut) Hazelnut 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3306-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO  cantaloupe cucumis melo   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3117 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cantaloupe (Cantaloupe) Cantaloupe 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3117-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, ORANGE CITRUS SINENSIS  orange citrus sinensis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3429 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Orange (Orange) Orange 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3429-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM  pea, green or english pisum sativum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3450 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pea (Pea) Pea 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3450-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, PEACH PRUNUS PERSICA  peach prunus persica   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3453 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Peach (Peach) Peach 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3453-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, PEANUT ARACHIS HYPOGAEA  peanut arachis hypogaea   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3456 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Peanut (Peanut) Peanut 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3456-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, PECAN CARYA ILLINOENSIS  pecan carya illinoensis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3462 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pecan (Pecan) Pecan 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3462-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM  potato, white solanum tuberosum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3519 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potato (Potato) Potato 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3519-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, RICE, WHOLE GRAIN  rice, whole grain   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3549 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rice (Rice) Rice 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3549-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, RYE GRAIN  rye grain   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3555 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rye (Rye) Rye 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3555-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, SOYBEAN GLYCINE SOJA  soybean glycine soja   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3597 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Soybean (Soybean) Soybean 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3597-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, STRAWBERRY FRAGARIA CHILOENSIS  strawberry fragaria chiloensis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3627 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Strawberry (Strawberry) Strawberry 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3627-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, STRING BEAN MIX  string bean mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3075 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength String Bean (String Bean) String Bean 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3075-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, TOMATO NICOTIANA SPP.  tomato nicotiana spp.   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3657 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tomato (Tomato) Tomato 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3657-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, WALNUT, BLACK JUGLANS NIGRA  walnut, black juglans nigra   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3696 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Black Walnut (Black Walnut) Black Walnut 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3696-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, YEAST, BAKER SACCHAROMYCES CEREVISIAE  yeast, baker saccharomyces cerevisiae   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3714 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Yeast (Yeast) Yeast 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3714-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

FOOD - PLANT SOURCE, YEAST, BREWER SACCHAROMYCES CEREVISIAE  yeast, brewer saccharomyces cerevisiae   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-3717 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Yeast (Yeast) Yeast 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-3717-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS (WHOLE BODY) COCKROACH MIX  insects (whole body) cockroach mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-6585 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Periplaneta americana (Periplaneta americana) Periplaneta americana 0.1 g  in 1 mL Blatella germanica (Blatella germanica) Blatella germanica 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6585-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS INVICTA  ant, fire solenopsis invicta   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-6513 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis invicta (Solenopsis invicta) Solenopsis invicta 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6513-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS (WHOLE BODY), ANT, FIRE SOLENOPSIS RICHTERI  ant, fire solenopsis richteri   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-6514 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis richteri (Solenopsis richteri) Solenopsis richteri 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6514-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

INSECTS (WHOLE BODY), FIRE ANT MIX  insects (whole body), fire ant mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-6515 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis richteri (Solenopsis richteri) Solenopsis richteri 0.1 g  in 1 mL Solenopsis invicta (Solenopsis invicta) Solenopsis invicta 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6515-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - ALTERNARIA/HORMODENDRUM MIX  molds - alternaria/hormodendrum mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5003 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alternaria alternata (Alternaria alternata) Alternaria alternata 0.1 g  in 1 mL Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5003-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - MOLD MIX 10  molds - mold mix 10   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5137 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alternaria alternata (Alternaria alternata) Alternaria alternata 0.1 g  in 1 mL Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 0.025 g  in 1 mL Emericella nidulans (Emericella nidulans) Emericella nidulans 0.025 g  in 1 mL Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 0.025 g  in 1 mL Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 0.025 g  in 1 mL Fusarium oxysporum vasinfectum (Fusarium oxysporum vasinfectum) Fusarium oxysporum vasinfectum 0.1 g  in 1 mL Dendryphiella vinosa (Dendryphiella vinosa) Dendryphiella vinosa 0.1 g  in 1 mL Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 0.1 g  in 1 mL Mucor racemosus (Mucor racemosus) Mucor racemosus 0.1 g  in 1 mL Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 0.02 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.02 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.02 g  in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 0.02 g  in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 0.02 g  in 1 mL Phoma exigua var. exigua (Phoma exigua var. exigua) Phoma exigua var. exigua 0.1 g  in 1 mL Aureobasidium pullulans var. pullutans (Aureobasidium pullulans var. pullutans) Aureobasidium pullulans var. pullutans 0.1 g  in 1 mL Rhizopus stolonifer (Rhizopus stolonifer) Rhizopus stolonifer 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5137-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - MOLD MIX 4  molds - mold mix 4   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5002 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alternaria alternata (Alternaria alternata) Alternaria alternata 0.1 g  in 1 mL Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 0.025 g  in 1 mL Emericella nidulans (Emericella nidulans) Emericella nidulans 0.025 g  in 1 mL Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 0.025 g  in 1 mL Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 0.025 g  in 1 mL Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 0.1 g  in 1 mL Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 0.025 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.025 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.025 g  in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 0.025 g  in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 0.025 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5002-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS - TRICHOPHYTON MIX  molds - trichophyton mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5285 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trichophyton tonsurans (Trichophyton tonsurans) Trichophyton tonsurans 0.1 g  in 1 mL Trichophyton rubrum (Trichophyton rubrum) Trichophyton rubrum 0.1 g  in 1 mL Trichophyton mentagrophytes (Trichophyton mentagrophytes) Trichophyton mentagrophytes 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5285-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, PENICILLIUM MIX  molds, penicillium mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5169 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 0.1 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.1 g  in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 0.1 g  in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 0.1 g  in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5169-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS  alternaria tenuis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5009 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alternaria alternata (Alternaria alternata) Alternaria alternata 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5009-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS  aspergillus fumigatus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5021 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5021-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, ASPERGILLUS NIGER  aspergillus niger   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5033 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5033-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA  botrytis cinerea   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5049 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Botrytis cinerea (Botrytis cinerea) Botrytis cinerea 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5049-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS  candida albicans   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5053 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Candida albicans (Candida albicans) Candida albicans 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5053-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM  cephalosporium acremonium   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5057 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acremonium strictum (Acremonium strictum) Acremonium strictum 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5057-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA  curvularia spicifera   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5077 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cochliobolus spicifer (Cochliobolus spicifer) Cochliobolus spicifer 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5077-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM  epicoccum nigrum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5101 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Epicoccum nigrum (Epicoccum nigrum) Epicoccum nigrum 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5101-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, EPIDERMOPHYTON FLOCCOSUM  epidermophyton floccosum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5105 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Epidermophyton floccosum (Epidermophyton floccosum) Epidermophyton floccosum 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5105-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, FUSARIUM VASINFECTUM  fusarium vasinfectum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5113 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fusarium oxysporum vasinfectum (Fusarium oxysporum vasinfectum) Fusarium oxysporum vasinfectum 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5113-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, HELMINTHOSPORIUM INTERSEMINATUM  helminthosporium interseminatum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5125 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dendryphiella vinosa (Dendryphiella vinosa) Dendryphiella vinosa 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5125-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, HORMODENDRUM CLADOSPORIOIDES   hormodendrum cladosporioides   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5129 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5129-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, MUCOR RACEMOSUS  mucor racemosus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5145 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mucor racemosus (Mucor racemosus) Mucor racemosus 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5145-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PENICILLIUM NOTATUM  penicillium notatum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5209 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5209-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PHOMA HERBARUM  phoma herbarum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5221 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phoma exigua var. exigua (Phoma exigua var. exigua) Phoma exigua var. exigua 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5221-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, PULLULARIA PULLULANS  pullularia pullulans   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5233 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aureobasidium pullulans var. pullutans (Aureobasidium pullulans var. pullutans) Aureobasidium pullulans var. pullutans 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5233-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, RHIZOPUS NIGRICANS  rhizopus nigricans   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5232 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rhizopus stolonifer (Rhizopus stolonifer) Rhizopus stolonifer 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5232-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

MOLDS, RUSTS AND SMUTS, STEMPHYLIUM BOTRYOSUM  stemphylium botryosum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-5265 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pleospora tarda (Pleospora tarda) Pleospora tarda 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-5265-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, BAHIA GRASS PASPALUM NOTATUM  bahia grass paspalum notatum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1082 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Paspalum notatum pollen (Paspalum notatum pollen) Paspalum notatum pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1082-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, BROME, SMOOTH BROMUS INERMIS  brome, smooth bromus inermis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1238 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bromus inermis pollen (Bromus inermis pollen) Bromus inermis pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1238-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, CORN, CULTIVATED ZEA MAYS  corn, cultivated zea mays   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1415 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zea mays pollen (Zea mays pollen) Zea mays pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1415-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, JOHNSON GRASS SORGHUM HALEPENSE  johnson grass sorghum halepense   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1745 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1745-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, OATS, COMMON, CULTIVATED AVENA SATIVA  oats, common, cultivated avena sativa   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2042 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avena sativa pollen (Avena sativa pollen) Avena sativa pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2042-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - GRASSES, SOUTHERN GRASS MIX   pollens - grasses, southern grass mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-0855 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Poa pratensis pollen (Poa pratensis pollen) Poa pratensis pollen 100000 [BAU]  in 1 mL Dactylis glomerata pollen (Dactylis glomerata pollen) Dactylis glomerata pollen 100000 [BAU]  in 1 mL Agrostis gigantea pollen (Agrostis gigantea pollen) Agrostis gigantea pollen 100000 [BAU]  in 1 mL Phleum pratense pollen (Phleum pratense pollen) Phleum pratense pollen 100000 [BAU]  in 1 mL Anthoxanthum odoratum pollen (Anthoxanthum odoratum pollen) Anthoxanthum odoratum pollen 100000 [BAU]  in 1 mL Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 0.05 g  in 1 mL Cynodon dactylon pollen (Cynodon dactylon pollen) Cynodon dactylon pollen 10000 [BAU]  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-0855-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ACACIA ACACIA LONGIFOLIA  acacia longifolia   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1007 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acacia longifolia pollen (Acacia longifolia pollen) Acacia longifolia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1007-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ALDER, RED ALNUS RUBRA  alder, red alnus rubra   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1019 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alnus rubra pollen (Alnus rubra pollen) Alnus rubra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1019-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ASH, WHITE FRAXINUS AMERICANA  ash, white fraxinus americana   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1061 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1061-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BEECH, AMERICAN FAGUS GRANDIFOLIA  beech, american fagus grandifolia   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1121 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1121-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BIRCH MIX   birch mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1169 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 0.05 g  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 0.05 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1169-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, BOXELDER/MAPLE MIX  boxelder/maple mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1214 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 0.05 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.05 g  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1214-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CEDAR, MOUNTAIN JUNIPERUS ASHEI  cedar, mountain juniperus ashei   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1337 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juniperus ashei pollen (Juniperus ashei pollen) Juniperus ashei pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1337-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CEDAR, RED JUNIPERUS VIRGINIANA  cedar, red juniperus virginiana   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1340 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juniperus virginiana pollen (Juniperus virginiana pollen) Juniperus virginiana pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1340-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, COTTONWOOD, COMMON POPULUS DELTOIDES  cottonwood, common populus deltoides   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1436 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1436-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CYPRESS, ARIZONA CUPRESSUS ARIZONICA  cypress, arizona cupressus arizonica   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1451 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cupressus arizonica pollen (Cupressus arizonica pollen) Cupressus arizonica pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1451-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, CYPRESS, BALD TAXODIUM DISTICHUM  cypress, bald taxodium distichum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1454 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Taxodium distichum pollen (Taxodium distichum pollen) Taxodium distichum pollen 0.02 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1454-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ELM, AMERICAN ULMUS AMERICANA  elm, american ulmus americana   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1541 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1541-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, ELM, CHINESE ULMUS PARVIFOLIA  elm, chinese ulmus parvifolia   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1547 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ulmus parvifolia pollen (Ulmus parvifolia pollen) Ulmus parvifolia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1547-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, EUCALYPTUS (BLUE GUM) EUCALYPTUS GLOBULUS  eucalyptus (blue gum) eucalyptus globulus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1565 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Eucalyptus globulus pollen (Eucalyptus globulus pollen) Eucalyptus globulus pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1565-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, GUM, SWEET LIQUIDAMBAR STYRACIFLUA  gum, sweet liquidambar styraciflua   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1661 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Liquidambar styraciflua pollen (Liquidambar styraciflua pollen) Liquidambar styraciflua pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1661-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, HACKBERRY CELTIS OCCIDENTALIS  hackberry celtis occidentalis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1664 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Celtis occidentalis pollen (Celtis occidentalis pollen) Celtis occidentalis pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1664-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, HICKORY, SHAGBARK CARYA OVATA  hickory, shagbark carya ovata   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1703 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1703-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, LINDEN (BASSWOOD) TILIA AMERICANA  linden (basswood) tilia americana   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1802 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tilia americana pollen (Tilia americana pollen) Tilia americana pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1802-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MAPLE, HARD ACER SACCHARUM  maple, hard acer saccharum   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1832 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1832-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MESQUITE, PROSOPIS JULIFLORA  mesquite, prosopis juliflora   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1877 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Prosopis juliflora pollen (Prosopis juliflora pollen) Prosopis juliflora pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1877-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, MULBERRY MIX  mulberry mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1910 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Morus alba pollen (Morus alba pollen) Morus alba pollen 0.05 g  in 1 mL Morus rubra pollen (Morus rubra pollen) Morus rubra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1910-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OAK MIX  oak mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2036 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.05 g  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 0.05 g  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2036-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OAK, RED QUERCUS RUBRA  oak, red quercus rubra   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2015 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2015-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, OLIVE OLEA EUROPAEA  olive olea europaea   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2051 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Olea europaea pollen (Olea europaea pollen) Olea europaea pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2051-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PECAN CARYA CARYA ILLINOENSIS  pecan carya carya illinoensis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2099 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2099-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PEPPER TREE, CALIFORNIA SCHINUS MOLLE  pepper tree, california schinus molle   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2108 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Schinus molle pollen (Schinus molle pollen) Schinus molle pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2108-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PINE MIX  pine mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2204 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pinus contorta pollen (Pinus contorta pollen) Pinus contorta pollen 0.05 g  in 1 mL Pinus ponderosa pollen (Pinus ponderosa pollen) Pinus ponderosa pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2204-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, PRIVET LIGUSTRUM VULGARE  privet ligustrum vulgare   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2252 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ligustrum vulgare pollen (Ligustrum vulgare pollen) Ligustrum vulgare pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2252-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, RUSSIAN OLIVE ELAEAGNUS ANGUSTIFOLIA  russian olive elaeagnus angustifolia   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2360 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Elaeagnus angustifolia pollen (Elaeagnus angustifolia pollen) Elaeagnus angustifolia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2360-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, SYCAMORE, AMERICAN (EASTERN) PLATANUS OCCIDENTALLIS  sycamore, american (eastern) platanus occidentallis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2564 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2564-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 11  tree mix 11   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2620 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 0.05 g  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 0.05 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.05 g  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.05 g  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 0.05 g  in 1 mL Ulmus Americana pollen (Ulmus Americana pollen) Ulmus Americana pollen 0.05 g  in 1 mL Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 0.05 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.05 g  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.05 g  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 0.05 g  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2620-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 5  tree mix 5   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2858 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 0.05 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.017 g  in 1 mL Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 0.017 g  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 0.017 g  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.017 g  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 0.017 g  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 0.017 g  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 0.05 g  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2858-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE MIX 6  tree mix 6   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2859 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 0.05 g  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 0.05 g  in 1 mL Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 0.017 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.017 g  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 0.017 g  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.05 g  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 0.05 g  in 1 mL Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2859-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, TREE OF HEAVEN AILANTHUS ALTISSIMA  tree of heaven ailanthus altissima   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2600 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ailanthus altissima pollen (Ailanthus altissima pollen) Ailanthus altissima pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2600-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, WALNUT, BLACK JUGLANS NIGRA  walnut, black juglans nigra   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2627 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2627-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - TREES, WILLOW, BLACK SALIX NIGRA  willow, black salix nigra   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2678 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2678-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, COCKLEBUR XANTHIUM STRUMARIUM  cocklebur xanthium strumarium   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1406 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1406-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS  goldenrod solidago canadensis   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1631 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solidago canadensis pollen (Solidago canadensis pollen) Solidago canadensis pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1631-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, LAMB QUARTERS CHENOPODIUM ALBUM  lamb quarters chenopodium album   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1787 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1787-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, NETTLE URTICA DIOICA  nettle urtica dioica   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1946 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urtica dioica pollen (Urtica dioica pollen) Urtica dioica pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1946-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, PIGWEED, ROUGH REDROOT AMARANTHUS RETROFLEXUS  pigweed, rough redroot amaranthus retroflexus   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2126 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2126-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, PLANTAIN, ENGLISH PLANTAGO LANCEOLATA  plantain, english plantago lanceolata   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2213 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Plantago lanceolata pollen (Plantago lanceolata pollen) Plantago lanceolata pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2213-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, GIANT AMBROSIA TRIFIDA  ragweed, giant ambrosia trifida   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2294 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ambrosia trifida pollen (Ambrosia trifida pollen) Ambrosia trifida pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2294-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED. WESTERN AMBROSIA PSILOSTACHYA  ragweed. western ambrosia psilostachya   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2309 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ambrosia psilostachya pollen (Ambrosia psilostachya pollen) Ambrosia psilostachya pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2309-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, RUSSIAN THISTLE SALSOLA KALI  russian thistle salsola kali   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2363 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salsola kali pollen (Salsola kali pollen) Salsola kali pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2363-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SAGEBRUSH, MUGWORT ARTEMISIA VULGARIS  sagebrush, mugwort artemisia vulgaris   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2414 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Artemisia vulgaris pollen (Artemisia vulgaris pollen) Artemisia vulgaris pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2414-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SCALE, WING (SHAD) ATRIPLEX CANESCENS  scale, wing (shad) atriplex canescens   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2483 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atriplex canescens pollen (Atriplex canescens pollen) Atriplex canescens pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2483-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SCOTCH BROOM CYTISUS SCOPARIUS  scotch broom cytisus scoparius   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2486 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cytisus scoparius (Cytisus scoparius) Cytisus scoparius 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2486-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS AND GARDEN PLANTS, SORREL, SHEEP RUMEX ACETOSELLA  sorrel, sheep rumex acetosella   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2507 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2507-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, CARELESS WEED AMARANTHUS PALMERI  careless weed amaranthus palmeri   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1298 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amaranthus palmeri pollen (Amaranthus palmeri pollen) Amaranthus palmeri pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1298-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, CARELESS/PIGWEED MIX  careless/pigweed mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1301 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amaranthus palmeri pollen (Amaranthus palmeri pollen) Amaranthus palmeri pollen 0.05 g  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1301-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, DOCK/SORREL MIX  pollens - weeds, dock/sorrel mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1517 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 0.05 g  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1517-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, GIANT, SHORT, WESTERN RAGWEED MIX  giant, short, western ragweed mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2318 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ambrosia trifida pollen (Ambrosia trifida pollen) Ambrosia trifida pollen 0.05 g  in 1 mL Ambrosia artemisiifolia pollen (Ambrosia artemisiifolia pollen) Ambrosia artemisiifolia pollen 0.05 g  in 1 mL Ambrosia psilostachya pollen (Ambrosia psilostachya pollen) Ambrosia psilostachya pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2318-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, KOCHIA SCOPARIA  kochia scoparia   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1781 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Kochia scoparia pollen (Kochia scoparia pollen) Kochia scoparia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1781-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, MARSHELDER/POVERTY MIX  pollens - weeds, marshelder/poverty mix   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-1859 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iva axillaris pollen (Iva axillaris pollen) Iva axillaris pollen 0.05 g  in 1 mL Iva annua var. annua pollen (Iva annua var. annua pollen) Iva annua var. annua pollen 0.05 g  in 1 mL Iva xanthifolia pollen (Iva xanthifolia pollen) Iva xanthifolia pollen 0.05 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1859-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

POLLENS - WEEDS, WEED MIX 2630  weed mix 2630   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65044-2630 Route of Administration PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 0.05 g  in 1 mL Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 0.05 g  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 0.05 g  in 1 mL Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 0.025 g  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 0.025 g  in 1 mL

Inactive Ingredients Ingredient Name Strength glycerin   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2630-1 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103888	04/19/1941

Labeler - Hollister-Stier Laboratories LLC (069263643)

Registrant - Hollister-Stier Laboratories LLC (069263643)

Establishment
Name	Address	ID/FEI	Operations
Hollister-Stier Laboratories		069263643	manufacture

Revised: 06/2009Hollister-Stier Laboratories LLC