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 
DUST, HOUSE MIXTURE  - house dust injection, solution 
AP HOUSE DUST MIX  - 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  - quahog injection, solution 
FOOD - FISH AND SHELLFISH, CODFISH GADUS CALLARIAS  - cod injection, solution 
FOOD - FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI  - crab leg 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, AMERICAN PERIPLANETA AMERICANA  - periplaneta americana injection, solution 
INSECTS (WHOLE BODY) COCKROACH, GERMAN BLATELLA GERMANICA  - blatella germanica injection, solution 
INSECTS (WHOLE BODY) COCKROACH MIX  - periplaneta americana and blatella germanica 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, GRASS MIX 8  - poa pratensis pollen, cynodon dactylon pollen, sorghum halepense pollen, agrostis gigantea pollen and phleum pratense 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 - GRASSES, SOUTHERN GRASS MIX 10TH OF CONCENTRATE  - 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, BOTTLE BRUSH CALLISTEMON SPP.  - callistemon citrinus 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, MELALEUCA (PUNK TREE) MELALEUCA QUINQUENERVIA  - melaleuca quinquenervia 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, PALM, QUEEN COCOS PLUMOSA  - syagrus romanzoffiana pollen injection, solution 
POLLENS - TREES, PALO VERDE CERCIDIUM FLORIDUM  - cercidium floridum ssp. floridum 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, DOG FENNEL, EASTERN EUPATORIUM CAPILLIFOLIUM  - eupatorium capillifolium pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, GOLDENROD SOLIDAGO CANADENSIS  - solidago canadensis pollen injection, solution 
POLLENS - WEEDS AND GARDEN PLANTS, LAMBS 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 flowering top 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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ALLERGENIC EXTRACTS IN BULK VIALS

DESCRIPTION

The allergenic extract in this vial is referred to as a "bulk" extract or stock concentrate since it is designed primarily for the physician equipped to prepare dilutions and mixtures as required. The extract is sterile and intended for subcutaneous injection for immunotherapy and scratch, prick or puncture for diagnosis. Unless specified otherwise, the concentration of extract supplied will in most cases be expressed in weight to volume (e.g., 1:10 or 1:20 w/v) and will be the strongest available. Where mixtures of pollens and non-pollens have been ordered, the mixed extract will be treated as a pollen mixture. To insure maximum potency for the entire dating period, all bulk concentrates will contain 50% volume to volume (v/v) glycerin unless otherwise requested. Dilutions will also be prepared with 50% (v/v) glycerin unless another diluent is specified.
Source materials utilized in allergenic extract products include pollens, molds, animal epidermals, insects, foods and environmental materials.
Pollens are collected using techniques such as waterset or vacuuming, cleaned and purified to greater than 99% single specie pollen (less than 1% foreign particle presence).
Molds are typically grown on synthetic nutrient medias and are derived from the surface growth (mycelia).
Animal source materials are collected from animals deemed to be healthy at the time of collection by a veterinarian or individual trained and certified by a veterinarian. Epidermals include feathers, hair and dander, or the whole epidermal (pelt) as described on product labeling.
Regular process epidermals are extractions of the source material without additional processing, except that certain materials are defatted. AP™ (acetone precipitated) epidermal source materials are derived from the precipitate formed when acetone is added to an aqueous extract. The resulting precipitate is dried, and becomes the source material for the AP™ product.
Insects are collected in whole body form. Extractions take place as whole body or ground insects.
Information on Foods and other Environmental source materials can be obtained by contacting our Customer Service Department.
The following is a brief summary of the six methods of describing allergenic product concentration.

1. Weight to volume (w/v). Weight to volume (w/v) describes the weight of allergenic source material added to a given volume of extracting fluid. A 1:10 w/v extract, e.g., indicates that the solution contains the extractable material from one gram of raw material added to each 10 mL Glycero-Coca's or 10 mL Coca's extracting fluid. The amount and composition of extracted materials will vary with the type of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. Pollens are typically extracted at a 1:20 w/v ratio in Glycero-Coca's while Coca's extracts are 1:10 w/v. Epidermal, environmental, regular molds and insect products are typically extracted at 1:10 w/v. AP™ (acetone precipitated) epidermal products are prepared at a 1:50 w/v concentration (i.e., 1 gram of dried precipitate in 50 mL of reconstitution fluid). AP™ Dog Hair-Dander is prepared at 1:100 w/v concentration. (i.e., 1 gram of dried precipitate in 100 mL of reconstitution fluid.)

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 is reproducible from lot to lot. The amount of protein nitrogen extracted from the source material is influenced by such factors as the type of antigen, the extracting fluid, duration of extraction, pH, temperature and other variables. Allergenic materials make up a variable proportion of the total protein of an extract. Most allergenic extracts are assayed for PNU. Specific PNU information is available upon request.

3. Amb a 1. Of the many allergens from Short Ragweed which have been purified and characterized [Amb a 1 3 (also known as Antigen E), Amb a 2 3 (also known as Antigen K), Ra3 4, Ra4 (BPA-R) 5, Ra5 6, Ra6, Ra7, Ra87, and cytochrome C 8], Amb a 1 is considered the most important and has been selected as the basis for standardization. Extracts of Short Ragweed containing Amb a 1 are diffused in agar against standard anti-serum to Amb a 1, and compared to the diffusion of standard Amb a 1 solutions. The amount of Amb a 1 is expressed as units of Amb a 1 per mL of extract. A Short Ragweed pollen extracted at 1:20 (w/v) usually assays within a range of 50,000 to 70,000 PNU/mL and 100 to 300 units of Amb a 1 per mL.
The Amb a 1 concentration of any Short Ragweed extract which is diluted with a diluent or other allergenic extracts is determined by calculation. The resulting Amb a 1 value does not reflect the total potency of the product if Short Ragweed extract is mixed with another allergenic extract.

4. Allergy Units per mL (AU/mL). The potency of extracts labeled in Allergy Units (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).

5. Bioequivalent Allergy Units per mL (BAU/mL). Other standardized allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by in vitro assay or major allergen content) to CBER, FDA Reference Preparations. The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.9 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50, Bioequivalent Allergy Units are assigned as follows:

BAU/mL	D50 Range
100,000	13.9 - 15.9
10,000	10.9 - 12.9
1,000	8.8 - 10.8
100	6.7 - 8.7

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.

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

e.g. Concentrate
50% Short Ragweed 1:20 w/v
25% Std. Cat Pelt 10,000 BAU/mL
25% Mite D. farinae 10,000 AU/mL

Should the physician choose to calculate the actual strength of each component in the "Concentrate" mixture, the following formulation may be used:

Actual Allergen Strength in Concentrate	=	Allergen Manufacturing Strength	X	% Allergen in Formulation (by volume or parts)

Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin, or 0.4% phenol, as indicated on the vial label. Additional ingredients are 0.5% sodium chloride, and 0.275% sodium bicarbonate.

CLINICAL PHARMACOLOGY

The mechanism by which hyposensitization is achieved is not known completely. It has been shown that repeated injections of appropriate allergenic extracts will ameliorate the intensity of allergic symptoms upon contact with the allergen.11, 12, 13, 14 Clinical studies which address the efficacy of immunotherapy are available. The allergens which have been studied are cat, mite, and some pollen extracts.10, 15, 16, 17, 18, 19
IgE antibodies bound to receptors on mast cell membranes are required for the allergic reaction, and their level is probably related to serum IgE concentrations. Immunotherapy has been associated with decreased levels of IgE, and also with increases in allergen specific IgG "blocking" antibody.
The histamine release response of circulating basophils to a specific allergen is reduced in some patients by immunotherapy, but the mechanism of this change is not clear.
Further study and clarification of the relationships among changes in blocking antibody, reaginic antibody, and mediator-releasing cells, and between these three factors and successful immunotherapy, is needed.

INDICATIONS AND USAGE

20,21,22,23

Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.
The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen.
Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to dog dander in kennel owners and employees, dog breeders, research workers, veterinarians, etc.
Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur with the highly reactive allergen.

CONTRAINDICATIONS

There are no known absolute contraindications to immunotherapy. See PRECAUTIONS and WARNINGS.
Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those 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 allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1
Treat patients only with allergens to which they are allergic by skin test reaction, have a history of symptoms on exposure, and are likely to be exposed to again.
Any injections, including immunotherapy, should be avoided in patients with a bleeding tendency. Patients on 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 systemic reactions.2
Since there are differences of opinion concerning the possibility of routine immunizations exacerbating autoimmune diseases, immunotherapy should be given cautiously to patients with other immunologic diseases and only if the risk from exposure is greater than the risk of exacerbating the underlying disorder.

WARNINGS

See WARNINGS box at the beginning of this package insert. See also PRECAUTIONS.
Allergenic extracts must be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma; (2) infection or flu accompanied by fever; (3) any evidence of an excessively large local or any generalized reaction during the initial stages of immunotherapy or during maintenance therapy, and/or (4) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. Do not administer immunotherapy during a period of symptoms due to exposure. Since the individual components of the extract are those to which the patient is allergic, and to which s/he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly when the antigen load from exposure plus the injected antigen exceeds the patient's antigen tolerance.
THE CONCENTRATE MUST NOT BE INJECTED AT ANY TIME UNLESS TOLERANCE HAS BEEN ESTABLISHED. DILUTE CONCENTRATED EXTRACTS WITH STERILE DILUENT FOR SKIN TESTING AND IMMUNOTHERAPY.
INJECTIONS MUST NEVER BE GIVEN INTRAVENOUSLY. Subcutaneous injection is recommended. Intracutaneous or intramuscular injection may produce large local reactions or be excessively painful.
AFTER INSERTING NEEDLE SUBCUTANEOUSLY, BUT BEFORE INJECTING, ALWAYS WITHDRAW THE PLUNGER SLIGHTLY. IF BLOOD APPEARS IN THE SYRINGE, CHANGE NEEDLE AND GIVE THE INJECTION IN ANOTHER SITE.

IF CHANGING TO A DIFFERENT LOT OF EXTRACT: All extracts lose potency over time, and a fresh extract could have an effective potency that is substantially greater than that of the old extract. Even though it is the same formula and concentration, the first dose from the new vial should not exceed 50% of the previous dose.
IF THE EXTRACT PREVIOUSLY USED WAS FROM ANOTHER MANUFACTURER: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be insured. The starting dose of the extract therefore should be greatly decreased even though the extract is the same formula and dilution. In general, a dose reduction to 50% of the previous product dose should be adequate, but each situation must be evaluated separately considering the patient's history of sensitivity, tolerance of previous injections, and other factors. If the patient tolerates a 50% decrease, the next dose could be raised to the previous dose amount. If the decrease is greater than 50%, the next dose would need to be determined by the allergist, depending on the situation. Dose intervals should not exceed one week when rebuilding dose. See DOSAGE AND ADMINISTRATION.
IF A PROLONGED PERIOD OF TIME HAS ELAPSED SINCE THE LAST INJECTION: Patients may lose tolerance for allergen injections during prolonged periods between doses. The duration of tolerance is an individual characteristic and varies from patient to patient. In general, the longer the lapse in the injection schedule, the greater dose reduction required. If the interval since last dose is over four weeks, perform skin tests to determine starting dose. See DOSAGE AND ADMINISTRATION.
IF THE PREVIOUS EXTRACT WAS OUTDATED: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under refrigerated storage conditions (2° - 8°C). During the storage of extracts, even under ideal conditions, some loss of potency occurs. For this reason, extracts should not be used beyond their expiration date. If a patient has been receiving injections of an outdated extract, s/he may experience excessive local or systemic reactions when changed to a new and possibly more potent extract. In general, the longer the material has been outdated, the greater the dose reduction necessary for the fresh extract.
IF CHANGING FROM ALUM-ADSORBED TO AQUEOUS OR GLYCERINATED EXTRACTS: When the patient was previously receiving alum-adsorbed or alum-precipitated extract, the safest course is to start over as though the patient had not been receiving immunotherapy. See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS.
IF ANY OTHER CHANGES HAVE BEEN MADE IN THE EXTRACT CONCENTRATE FORMULA: Changes other than those listed above may include situations such as a redistribution of component parts or percentages, a difference in extracting fluid (i.e., change from non-glycerin extracts to 50% glycerin extracts), combining two or more stock concentrates, or any other change. It should be recognized that any change in formula can affect a patient's tolerance of the treatment. The usual 1/2 of the previous dose for a new extract may produce an adverse reaction; extra dilutions are recommended whenever starting a revised formula. The greater the change, the greater the number of dilutions required.

Proper selection of the dose and careful injection should prevent most systemic reactions. It must be remembered that allergenic extracts are highly potent in sensitive individuals, and that systemic reactions of varying degrees of severity may occur, including urticaria, rhinitis, conjunctivitis, wheezing, coughing, angioedema, hypotension, bradycardia, pallor, laryngeal edema, fainting, or even anaphylactic shock and death, as described under ADVERSE REACTIONS. Patients should be informed of this, and the precautions should be discussed prior to immunotherapy. (See PRECAUTIONS.) Severe systemic reactions should be treated as indicated in ADVERSE REACTIONS. Refer to WARNINGS box.

PRECAUTIONS

1. General

The presence of asthmatic signs and symptoms appear to be an indicator for severe reactions following allergy injections. An assessment of airway obstruction either by measurement of peak flow or an alternate procedure may provide a useful indicator as to the advisability of administering an allergy injection.1, 24, 25, 26, 27
Concentrated extracts must not be injected unless tolerance has been established. Concentrated extracts must be diluted prior to use: See DOSAGE and ADMINISTRATION for detailed instructions on the dilution of allergenic extracts.
Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Allergenic extracts diluted with sterile Albumin Saline with Phenol (0.4%) may be more potent than extracts diluted with diluents which do not contain stabilizers. When switching from non-stabilized to stabilized diluent, consider weaker initial dilutions for both intradermal testing and immunotherapy.
Sterile solutions, vials, syringes, etc. should be used and aseptic precautions observed in making dilutions.
To avoid cross-contamination, do not use the same needle to withdraw materials from vials of more than one extract, or extract followed by diluent.
A sterile tuberculin syringe graduated in 0.01 mL units and with a needle at least 5/8" long should be used to measure each dose from the appropriate dilution.
Aseptic techniques should always be employed when injections of allergenic extracts are being administered. A separate sterile syringe should be used for each patient to prevent transmission of hepatitis and other infectious agents from one person to another.
Patient reactions to previous injections should be reviewed before each new injection, so that dosage can be adjusted accordingly. See ADVERSE REACTIONS and WARNINGS.
Rarely, a patient is encountered who develops systemic reactions to minute doses of allergen and does not demonstrate increasing tolerance to injections after several months of treatment. If systemic reactions or excessive local responses occur persistently at very small doses, efforts at immunotherapy should be stopped.
PATIENTS SHOULD BE OBSERVED IN THE OFFICE FOR AT LEAST 30 MINUTES AFTER SKIN TESTING AND EACH TREATMENT INJECTION. Most severe reactions will occur within this time period, and rapid treatment measures should be instituted. See ADVERSE REACTIONS for such treatment measures.
In order to avoid darkening and possible precipitation, do not dilute the following extracts with solutions containing phenol: Privet pollen and food extracts of White Potato, Corn, Oat, Rye, and Wheat. Injections of such extracts discolored by reaction with phenol may produce a lasting tattoo-like discoloration of the skin.

2. Information for Patients

Patients should be instructed in the recognition of adverse reactions to immunotherapy, and in particular, to the symptoms of shock. (See WARNINGS box at the beginning of this package insert.) Patients should be made to understand the importance of a 30 minute observation period, and be cautioned to return to the office promptly if symptoms occur after leaving. Patients should be instructed to report any symptoms of exposure to the allergen, so the physician can adjust the dosage appropriately.

3. Drug Interactions

Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those 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 allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1
Patients on 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.2 (See WARNINGS). 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. 28 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.28, 29
Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. 30 Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites.31

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

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. The physician must carefully consider the benefit-to-risk ratio to both patient and fetus, of performing skin testing or continuing immunotherapy during pregnancy. The recommended precautions (See WARNINGS AND PRECAUTIONS) for preventing adverse reactions are especially important in the pregnant patient. Based on the physician's discretion, immunotherapy maintenance doses may be continued during pregnancy if the patient has not experienced adverse side effects. Immunotherapy is generally not initiated during pregnancy due to the risks associated with systemic reactions and their treatment. 33

6. Nursing Mothers

There are no current studies on the secretion of allergenic extract components in human milk or their 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

Since dosage for the pediatric population is the same as for adults 34, 35 larger volumes of solution may produce excessive discomfort. Therefore, in order to achieve the total dose required, the volume of the dose may need to be divided into more than one injection per visit.

8. Geriatric Use

The reactions from immunotherapy can be expected to be the same in elderly patients as in younger ones. Elderly patients may be more likely to be on medication that could block the effect of epinephrine which could be used to treat serious reactions, or they could be more sensitive to the cardiovascular side effect of epinephrine because of pre-existing cardiovascular disease. 36

ADVERSE REACTIONS

Physicians administering allergenic extract testing or treatment materials should be experienced in the treatment of severe systemic reactions. See WARNINGS box at the beginning of this package insert.
1. Local Reactions
Some erythema, swelling or pruritus at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours. Local reactions (erythema or swelling) which exceed 4-5 cm in diameter are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again. Large persistent local reactions may be treated by local cold, wet dressings and/or the use of oral antihistamines. They should be considered a warning of possible severe systemic reactions and an indication of the need for temporarily reduced dosages. A mild burning immediately after the injection is to be expected. This usually subsides in 10 to 20 seconds.

2. Systemic Reactions
With careful attention to dosage and administration, systemic reactions occur infrequently, but it cannot be overemphasized that in sensitive individuals, any injection could result in anaphylactic shock. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Most severe systemic reactions will begin within a 30 minute time period, but systemic reactions may occur at any time after skin tests or immunotherapy. Symptoms may range from mild to life-threatening (due to anaphylaxis)as described below.
Other possible systemic reactions which may occur in varying degrees of severity are laryngeal edema, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low. 1, 37
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 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 DOSAGE:
ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: 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 possibly vasoactive drugs. Airway patency should be insured. Oxygen should be given by mask. Intravenous antihistamine, inhaled bronchodilators, theophylline and/or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given. Emergency resuscitation measures and personnel trained in their use must be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures [Ref. J. Allergy and Clinical Immunology, 77(2):p. 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.
Severe systemic reactions mandate a decrease of at least 50% in the next dose, followed by cautious increases. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose.

3. Adverse Event Reporting
Report all adverse events to Hollister-Stier Laboratories LLC, Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

OVERDOSE SECTION

See ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION
1. General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response, and tolerance to the extract administered during the early phases of an injection regimen.
Allergen extracts should be administered using a sterile syringe with 0.01 mL gradations and a 25-27 gauge x 1/2" to 5/8" needle. The injections are given subcutaneously. The most common sites of injection are the lateral aspect of the upper arm or thigh. Intracutaneous or intramuscular injections may produce large local reactions and may be very painful.
Sterile aqueous diluent containing human serum albumin [Albumin Saline with Phenol (0.4%)] or diluent of 50% glycerin may be used when preparing dilutions of the concentrate for immunotherapy. Dilutions should be made accurately and aseptically, using sterile diluent, vials, syringes, etc. Mix thoroughly and gently by rocking or swirling. Maintain stock solutions and dilutions constantly at 2° - 8°C. To prepare dilutions for intradermal and therapeutic use, make a 1:10 dilution by adding 1.0 mL of the Concentrate to 9.0 mL of sterile aqueous diluent. Subsequent serial dilutions are made in a similar manner.
Following is a suggested schedule for average patients and will be satisfactory in most cases. However, the degree of sensitivity varies in many patients. The size of the dose should be adjusted according to the patient's tolerance and reaction. Decrease the size of the dose if the previous injection resulted in marked local or the slightest general reaction. Another dose should never be given until all reactions resulting from the previous dose have disappeared.
The starting dose should be based on skin tests of the extract to be used for immunotherapy. To determine the starting dose, begin intradermal testing with the most dilute extract preparation. Inject 0.02 mL and read the reaction after 15 minutes. Intradermal testing is continued with increasing concentrations of the extract until a reaction of 10-20 mm erythema ( ∑ E 0-40 mm) and/or a 5 mm wheal occurs. This concentration at a dose of 0.03 mL then can serve as a starting dose for immunotherapy. Subsequent doses can be increased by 0.03 mL to as high as 0.12 mL increments each time until 0.3 mL is reached, at which time a dilution 10 times as strong can be used, starting with 0.03 mL. Proceed in this way until a tolerance dose is reached or symptoms are controlled. Suggested maintenance dose for a pollen extract is 0.2 mL of the Concentrate, while for a non-pollen extract the maximum suggested dose is 0.5 mL of the Concentrate. Occasionally, higher doses are necessary to relieve symptoms. Special caution is required in administering doses greater than 0.2 mL. The interval between doses is normally 3 to 7 days during dose building regimen.
Normally immunotherapy can be started with a 1:100,000 dilution of extracts labeled in weight/volume. Certain therapeutic mixtures are labeled as Concentrate, (v/v) dilutions of Concentrate, Amb a 1, Allergy units/mL or Bioequivalent Allergy Units/mL. (See DESCRIPTION.) Strength of each antigen in the mixture is indicated in the product labeling. For beginning treatment, use at least a 1,000-fold dilution of the Concentrate extract for non-pollens, and at least a 10,000-fold dilution of the Concentrate extract for pollens.
In some patients, the dosage may be increased more rapidly than recommended above. In seasonal allergies, treatment should be started and the interval between doses regulated so that at least the first twenty doses will have been administered by the time symptoms are expected. Thus, the shorter the interval between the start of immunotherapy and the expected onset of symptoms, the shorter the interval between each dose. Some patients may even tolerate daily doses.
Should symptoms develop before the next injection is scheduled, the interval between doses should be decreased. Should allergic symptoms or local reactions develop shortly after the dose is administered, the size of the dose should be decreased. In seasonal allergies, it is often advisable to decrease the dose to one-half or one-quarter of the maximum dose previously attained if the patient has any seasonal symptoms.
A maintenance dose, the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions, is recommended for most patients. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of extract may be painful if glycerin is present. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment. The size of this dose and the interval between doses will vary and can be adjusted as necessary.
The interval between maintenance doses can be increased gradually from one week to 10 days, to two weeks, to three weeks, or even to four weeks, if tolerated. Repeat the doses at a given interval three or four times to check for untoward reactions before further increasing the interval. Protection is lost rapidly if the interval between doses is more than four weeks. (See WARNINGS.)
The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.

2. Pediatric Use

The dose for the pediatric population is the same as for adults.

3. Geriatric Use

The dose for elderly patients is the same as for adult patients under 65.36

HOW SUPPLIED

In 10 mL, 30 mL and 50 mL vials at the w/v, Concentrate, v/v dilution of Concentrate, AU/mL (Standardized Mite Extracts: D. farinae, D. pteronyssinus 10,000 and 30,000 AU/mL; Mite Mixtures: 5,000 AU/mL each species, or 15,000 AU/mL each species), BAU/mL (Standardized Cat Hair and Cat Pelt extracts: 10,000 BAU/mL; Standardized Grass extracts: 10,000 and 100,000 BAU/mL); Amb a 1 units/mL; or PNU/mL ordered by the physician. Please see the current Allergy Product Catalog.

STORAGE AND HANDLING

The expiration date is listed on the container label. To ensure the maximum potency, the extract and its dilutions should be stored at 2° - 8°C, and kept in this temperature range at all times, even during use. Dilutions are less stable than concentrates. If loss of potency is suspected, dilutions should be checked by skin testing with equal v/v dilutions of a freshly prepared dilution on individuals known to be allergic to the specific allergen.

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. Lockey, R.F., L.M. Benedict, P.C. Turkletaub, S.C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol., 79 (4): 660-677, 1987.
2. Jacobs, R.L., G.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.
3. Griffith, I.J., J. Pollock, D.G. Klapper, B.L. Rogers and A.K. Nault. Sequence Polymorphism of Amb a I and Amb a II, the Major Allergens in Ambrosia artemisiifolia (Short Ragweed). Int. Arch. Allergy Apply. Immunol., 96: 296-304, 1991.
4. Underdown, B. J. and L. Goodfriend. Isolation and characterization of an allergen from short ragweed pollen. Biochem. 8 (3): 980-989, 1969.
5. Griffiths, B. W and R. Brunet. Isolation of a basic protein antigen of low ragweed pollen. Can. J. Biochem. 49 (3): 396-400, 1971.
6. Lapkoff, C. B. and L. Goodfriend. Isolation of a low molecular weight ragweed allergen: Ra5. Int. Arch. Allergy Appl. Immunol. 46 (2): 215-229, 1974.
7. Hussain, R. and D. G. March. Characterization and allergenic activity of ragweed allergens Ra6, Ra7, Ra8. J. Allergy Clin. Immunol. 65 (3): 230, abstr. 218, 1980
8. Goodfriend, L., A. M. Choudhury, J. Del Carpio and T. P. King. Cytochrome C: New ragweed pollen allergen. Fed. Proc. 38 (3, part II): 1415, abstr. 6261, 1979.
9. Turkeltaub, P.C., MD, and S.C. Rastogi, PhD. Quantitative intradermal test procedure for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of bioequivalent allergy units to reference preparations using the ID50EAL method. Allergenics Products Testing Laboratory, Center for Biologics Evaluation and Research (CBER), FDA. Revised: November, 1994.
10. Norman, P. S. Postgraduate Course Presentation. An overview of immunotherapy, implications for the future. J. Allergy Clin. Immunol., 65 (2): 87-96, 1980.
11. Lowell, F. C. and W. Franklin. A "double-blind" study of treatment with aqueous allergenic extracts in cases of allergic rhinitis. J. Allergy, 34 (2):165-182, 1963.
12. Lowell, F. C. and W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N. Eng. J. Med. 273 (13): 675-679, 1965.
13. Zavazal, V. and A. Stajner. Immunologic changes during specific treatment of the atopic state. II. Acta. Allergol. 25 (1): 11-17, 1970.
14. Reisman, R. E., J. I. Wypych, and E. E. Arbesman. Relationship of immunotherapy, seasonal pollen exposure and clinical response to serum concentrations of total IgE and ragweed-specific IgE. Int. Arch. Allergy Appl. Immunol. 48 (6): 721-730, 1975.
15. Taylor, W. W., J. L. Ohman, F. C. Lowell. Immunotherapy in cat-induced asthma; double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy Clin. Immunol., 61 (5): 283-287, 1978.
16. Smith, A. P. Hyposensitization with Dermatophagoides pteronyssinus antigen: Trial in asthma induced by house dust. Br. Med. J., 4: 204-206, 1971.
17. Chapman, M. D., T. A. E. Platts-Mills, M. Gabriel, H. K. Ng, W. G. L. Allen, L. E.Hill, A. J. Nunn. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Int. Arch. Allergy Appl. Immunol., 61:431-440, 1980.
18. Norman, P. S., W. L. Winkenwerder. Maintenance immunotherapy in ragweed hay fever. J. Allergy, 74: 273-282, 1971.
19. Norman, P. S., W. L. Winkenwerder, L. M. Lichtenstein. Immunotherapy of hay fever with ragweed Antigen E; comparisons with whole pollen extract and placebos. J. Allergy, 42: 93-108, 1968.
20. Middleton, E., C. E. Reed and E. F. Ellis, editors. Allergy Principles and Practice. C. V. Mosby Co., St. Louis, 1978, pp. 877-898.
21. Sheldon, J. M., R. G. Lovell and K. P. Mathews. A Manual of Clinical Allergy, Second Edition. W. B. Saunders. Philadelphia, 1967, pp. 107-112.
22. Sherman, W. B. Hypersensitivity Mechanisms and Management. W. B. Saunders. Philadelphia, 1968, pp. 169-172.
23. Swineford, O. Asthma and Hay Fever. Charles C. Thomas. Springfield, IL, 1971, pp. 148-155.
24. Reid, M.J., R.F. Lockey, P.C. Turkletaub, T.A.E., Platts-Mills. Survey of fatalities from skin testing and immunotherapy. J. 0 Clin. Immunol. 92 (1): 6-15, July 1993.
25. Reid, M.J., G. Gurka. Deaths associated with skin testing and immunotherapy. J. Allergy Clin. Immunol. 97(1) Part 3:231, Abstract 195, January 1996.
26. Thompson, R.A., et al, report of a WHO/IUIS working group. The current status of allergen immunotherapy (hyposensitization). Allergy. 44: 369-379, 1989.
27. Malling, H.J., B. Weeke, et al, The European Academy of Allergology and Clinical Immunology. Position Papers. Allergy. 48 (Supplement 14): 9-82, 1993.
28. Pipkorn, U. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86,1988.
29. 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.
30. Rao, K.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.
31. Pipkorn, U., and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.
32. 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.
33. Li, J.T., R.F. Lockey, I.L. Bernstein, J.M. Ortnoy, R.A. Nicklas. Allergen Immunotherapy: A Practice Parameter. Ann. Allergy, Asthma and Immunotherapy 90 (1): 26, 2003.
34. Patterson, R., et al. Allergy Principles and Practice, 2nd ed. E. Middleton, Jr., C. E. Reed, E. F. Ellis, Ed., C. V. Mosby Co., 1983, St. Louis, MO, 1983, Chapter 52
35. Levy, D. A., L. M. Lichtenstein, E. O. Goldstein, and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigation, 50:360, 1971.
36. Peebles, R.S., Jr., B. Bochner, Howard J. Zeitz, ed. Anaphylaxis in the elderly. Immunology and Allergy Clinics of North America. 13 (3): 627-646, August 1993.
37. Turkeltaub, P.C., MD, and P.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.

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

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4855 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4855-2 10 mL In 1 VIAL None 2 65044-4855-3 30 mL In 1 VIAL None 3 65044-4855-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4811 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4811-2 10 mL In 1 VIAL None 2 65044-4811-3 30 mL In 1 VIAL None 3 65044-4811-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4824 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4824-2 10 mL In 1 VIAL None 2 65044-4824-3 30 mL In 1 VIAL None 3 65044-4824-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4083 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4083-2 10 mL In 1 VIAL None 2 65044-4083-3 30 mL In 1 VIAL None 3 65044-4083-4 50 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, DOG HAIR AND DANDER CANIS SPP.  dog hair canis spp.   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4085 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4085-2 10 mL In 1 VIAL None 2 65044-4085-3 30 mL In 1 VIAL None 3 65044-4085-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4349 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4349-2 10 mL In 1 VIAL None 2 65044-4349-3 30 mL In 1 VIAL None 3 65044-4349-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4352 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4352-2 10 mL In 1 VIAL None 2 65044-4352-3 30 mL In 1 VIAL None 3 65044-4352-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4401 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4401-2 10 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

DUST, HOUSE MIXTURE  dust, house mixture   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4700 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4700-2 10 mL In 1 VIAL None 2 65044-4700-3 30 mL In 1 VIAL None 3 65044-4700-4 50 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

DUST, HOUSE MIXTURE  dust, house mixture   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4703 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4703-2 10 mL In 1 VIAL None 2 65044-4703-3 30 mL In 1 VIAL None 3 65044-4703-4 50 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

DUST, HOUSE MIXTURE  dust, house mixture   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4704 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength House Dust (House Dust) House Dust 10000 [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 65044-4704-2 10 mL In 1 VIAL None 2 65044-4704-3 30 mL In 1 VIAL None 3 65044-4704-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4707 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-4707-2 10 mL In 1 VIAL None 2 65044-4707-3 30 mL In 1 VIAL None 3 65044-4707-4 50 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

AP HOUSE DUST MIX  ap house dust mix   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-4708 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-4708-2 10 mL In 1 VIAL None 2 65044-4708-3 30 mL In 1 VIAL None 3 65044-4708-4 50 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

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

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3077 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3077-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3173 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3173-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3248 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3248-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3254 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3254-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3509 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3509-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3380 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3380-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3389 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3389-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3191 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Quahog (Quahog) Quahog 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 65044-3191-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3203 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cod (Cod) Cod 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 65044-3203-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3215 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Crab Leg (Crab Leg) Crab Leg 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 65044-3215-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3362 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3362-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3565 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3565-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3584 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3584-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3674 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3674-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3014 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3014-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3020 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3020-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3041 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3041-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3107 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3107-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3125 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3125-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3134 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3134-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3140 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3140-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3212 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3212-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3305 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3305-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3116 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3116-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3428 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3428-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3449 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3449-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3452 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3452-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3455 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3455-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3461 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3461-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3518 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3518-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3548 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3548-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3554 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3554-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3596 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3596-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3626 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3626-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3074 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3074-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3656 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3656-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3695 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3695-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3713 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3713-2 10 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-3716 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-3716-2 10 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, AMERICAN PERIPLANETA AMERICANA  insects (whole body) cockroach, american periplaneta americana   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6580 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Periplaneta americana (Periplaneta americana) Periplaneta americana 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 65044-6580-2 10 mL In 1 VIAL None 2 65044-6580-3 30 mL In 1 VIAL None 3 65044-6580-4 50 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, GERMAN BLATELLA GERMANICA  insects (whole body) cockroach, german blatella germanica   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6581 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 65044-6581-2 10 mL In 1 VIAL None 2 65044-6581-3 30 mL In 1 VIAL None 3 65044-6581-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6584 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-6584-2 10 mL In 1 VIAL None 2 65044-6584-3 30 mL In 1 VIAL None 3 65044-6584-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6587 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6587-2 10 mL In 1 VIAL None 2 65044-6587-3 30 mL In 1 VIAL None 3 65044-6587-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6588 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Periplaneta americana (Periplaneta americana) Periplaneta americana 20000 [PNU]  in 1 mL Blatella germanica (Blatella germanica) Blatella germanica 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 65044-6588-2 10 mL In 1 VIAL None 2 65044-6588-3 30 mL In 1 VIAL None 3 65044-6588-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6589 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Periplaneta americana (Periplaneta americana) Periplaneta americana 20000 [PNU]  in 1 mL Blatella germanica (Blatella germanica) Blatella germanica 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6589-2 10 mL In 1 VIAL None 2 65044-6589-3 30 mL In 1 VIAL None 3 65044-6589-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6590 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Periplaneta americana (Periplaneta americana) Periplaneta americana 5000 [PNU]  in 1 mL Blatella germanica (Blatella germanica) Blatella germanica 5000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6590-2 10 mL In 1 VIAL None 2 65044-6590-3 30 mL In 1 VIAL None 3 65044-6590-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6518 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-6518-2 10 mL In 1 VIAL None 2 65044-6518-3 30 mL In 1 VIAL None 3 65044-6518-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-6517 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-6517-2 10 mL In 1 VIAL None 2 65044-6517-3 30 mL In 1 VIAL None 3 65044-6517-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5004 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5004-2 10 mL In 1 VIAL None 2 65044-5004-3 30 mL In 1 VIAL None 3 65044-5004-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5136 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5136-2 10 mL In 1 VIAL None 2 65044-5136-3 30 mL In 1 VIAL None 3 65044-5136-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5000 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5000-2 10 mL In 1 VIAL None 2 65044-5000-3 30 mL In 1 VIAL None 3 65044-5000-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5284 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5284-2 10 mL In 1 VIAL None 2 65044-5284-3 30 mL In 1 VIAL None 3 65044-5284-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5168 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5168-2 10 mL In 1 VIAL None 2 65044-5168-3 30 mL In 1 VIAL None 3 65044-5168-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5008 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5008-2 10 mL In 1 VIAL None 2 65044-5008-3 30 mL In 1 VIAL None 3 65044-5008-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5020 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5020-2 10 mL In 1 VIAL None 2 65044-5020-3 30 mL In 1 VIAL None 3 65044-5020-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5032 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5032-2 10 mL In 1 VIAL None 2 65044-5032-3 30 mL In 1 VIAL None 3 65044-5032-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5048 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5048-2 10 mL In 1 VIAL None 2 65044-5048-3 30 mL In 1 VIAL None 3 65044-5048-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5052 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5052-1 10 mL In 1 VIAL None 2 65044-5052-3 30 mL In 1 VIAL None 3 65044-5052-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5055 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Candida albicans (Candida albicans) Candida albicans 0.001 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 65044-5055-1 10 mL In 1 VIAL None 2 65044-5055-3 30 mL In 1 VIAL None 3 65044-5055-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5056 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5056-2 10 mL In 1 VIAL None 2 65044-5056-3 30 mL In 1 VIAL None 3 65044-5056-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5076 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5076-2 10 mL In 1 VIAL None 2 65044-5076-3 30 mL In 1 VIAL None 3 65044-5076-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5100 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5100-2 10 mL In 1 VIAL None 2 65044-5100-3 30 mL In 1 VIAL None 3 65044-5100-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5104 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5104-2 10 mL In 1 VIAL None 2 65044-5104-3 30 mL In 1 VIAL None 3 65044-5104-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5112 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5112-2 10 mL In 1 VIAL None 2 65044-5112-3 30 mL In 1 VIAL None 3 65044-5112-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5124 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5124-2 10 mL In 1 VIAL None 2 65044-5124-3 30 mL In 1 VIAL None 3 65044-5124-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5128 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5128-2 10 mL In 1 VIAL None 2 65044-5128-3 30 mL In 1 VIAL None 3 65044-5128-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5144 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5144-2 10 mL In 1 VIAL None 2 65044-5144-3 30 mL In 1 VIAL None 3 65044-5144-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5208 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5208-2 10 mL In 1 VIAL None 2 65044-5208-3 30 mL In 1 VIAL None 3 65044-5208-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5220 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5220-2 10 mL In 1 VIAL None 2 65044-5220-3 30 mL In 1 VIAL None 3 65044-5220-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5235 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5235-2 10 mL In 1 VIAL None 2 65044-5235-3 30 mL In 1 VIAL None 3 65044-5235-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5230 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5230-2 10 mL In 1 VIAL None 2 65044-5230-3 30 mL In 1 VIAL None 3 65044-5230-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-5264 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-5264-2 10 mL In 1 VIAL None 2 65044-5264-3 30 mL In 1 VIAL None 3 65044-5264-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1081 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1081-2 10 mL In 1 VIAL None 2 65044-1081-3 30 mL In 1 VIAL None 3 65044-1081-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1084 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Paspalum notatum pollen (Paspalum notatum pollen) Paspalum notatum pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1084-2 10 mL In 1 VIAL None 2 65044-1084-3 30 mL In 1 VIAL None 3 65044-1084-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1237 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1237-2 10 mL In 1 VIAL None 2 65044-1237-3 30 mL In 1 VIAL None 3 65044-1237-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1414 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1414-2 10 mL In 1 VIAL None 2 65044-1414-3 30 mL In 1 VIAL None 3 65044-1414-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1744 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1744-2 10 mL In 1 VIAL None 2 65044-1744-3 30 mL In 1 VIAL None 3 65044-1744-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1747 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1747-2 10 mL In 1 VIAL None 2 65044-1747-3 30 mL In 1 VIAL None 3 65044-1747-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2041 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2041-2 10 mL In 1 VIAL None 2 65044-2041-3 30 mL In 1 VIAL None 3 65044-2041-4 50 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, GRASS MIX 8  grass mix 8   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-0879 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 Cynodon dactylon pollen (Cynodon dactylon pollen) Cynodon dactylon pollen 10000 [BAU]  in 1 mL Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 0.05 g  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

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 65044-0879-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-0854 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-0854-2 10 mL In 1 VIAL None 2 65044-0854-3 30 mL In 1 VIAL None 3 65044-0854-4 50 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 10TH OF CONCENTRATE  pollens - grasses, southern grass mix   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-0856 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Poa pratensis pollen (Poa pratensis pollen) Poa pratensis pollen 10000 [BAU]  in 1 mL Dactylis glomerata pollen (Dactylis glomerata pollen) Dactylis glomerata pollen 10000 [BAU]  in 1 mL Agrostis gigantea pollen (Agrostis gigantea pollen) Agrostis gigantea pollen 10000 [BAU]  in 1 mL Phleum pratense pollen (Phleum pratense pollen) Phleum pratense pollen 10000 [BAU]  in 1 mL Anthoxanthum odoratum pollen (Anthoxanthum odoratum pollen) Anthoxanthum odoratum pollen 10000 [BAU]  in 1 mL Sorghum halepense pollen (Sorghum halepense pollen) Sorghum halepense pollen 0.005 g  in 1 mL Cynodon dactylon pollen (Cynodon dactylon pollen) Cynodon dactylon pollen 1000 [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 65044-0856-2 10 mL In 1 VIAL None 2 65044-0856-3 30 mL In 1 VIAL None 3 65044-0856-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1006 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1006-2 10 mL In 1 VIAL None 2 65044-1006-3 30 mL In 1 VIAL None 3 65044-1006-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1018 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1018-2 10 mL In 1 VIAL None 2 65044-1018-3 30 mL In 1 VIAL None 3 65044-1018-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1021 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alnus rubra pollen (Alnus rubra pollen) Alnus rubra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1021-2 10 mL In 1 VIAL None 2 65044-1021-3 30 mL In 1 VIAL None 3 65044-1021-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1060 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1060-2 10 mL In 1 VIAL None 2 65044-1060-3 30 mL In 1 VIAL None 3 65044-1060-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1120 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1120-2 10 mL In 1 VIAL None 2 65044-1120-3 30 mL In 1 VIAL None 3 65044-1120-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1168 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1168-2 10 mL In 1 VIAL None 2 65044-1168-3 30 mL In 1 VIAL None 3 65044-1168-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1171 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 0.1 g  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 0.1 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1171-2 10 mL In 1 VIAL None 2 65044-1171-3 30 mL In 1 VIAL None 3 65044-1171-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1172 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 20000 [PNU]  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 40000 [PNU]  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1172-2 10 mL In 1 VIAL None 2 65044-1172-3 30 mL In 1 VIAL None 3 65044-1172-4 50 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, BOTTLE BRUSH CALLISTEMON SPP.  bottle brush callistemon spp.   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1207 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Callistemon citrinus pollen (Callistemon citrinus pollen) Callistemon citrinus 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 65044-1207-2 10 mL In 1 VIAL None 2 65044-1207-3 30 mL In 1 VIAL None 3 65044-1207-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1213 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1213-2 10 mL In 1 VIAL None 2 65044-1213-3 30 mL In 1 VIAL None 3 65044-1213-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1216 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 0.1 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.1 g  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1216-2 10 mL In 1 VIAL None 2 65044-1216-3 30 mL In 1 VIAL None 3 65044-1216-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1217 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 40000 [PNU]  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 40000 [PNU]  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1217-2 10 mL In 1 VIAL None 2 65044-1217-3 30 mL In 1 VIAL None 3 65044-1217-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1336 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1336-2 10 mL In 1 VIAL None 2 65044-1336-3 30 mL In 1 VIAL None 3 65044-1336-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1339 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juniperus ashei pollen (Juniperus ashei pollen) Juniperus ashei pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1339-2 10 mL In 1 VIAL None 2 65044-1339-3 30 mL In 1 VIAL None 3 65044-1339-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1343 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1343-2 10 mL In 1 VIAL None 2 65044-1343-3 30 mL In 1 VIAL None 3 65044-1343-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1342 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juniperus virginiana pollen (Juniperus virginiana pollen) Juniperus virginiana pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1342-2 10 mL In 1 VIAL None 2 65044-1342-3 30 mL In 1 VIAL None 3 65044-1342-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1435 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1435-2 10 mL In 1 VIAL None 2 65044-1435-3 30 mL In 1 VIAL None 3 65044-1435-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1438 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 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 65044-1438-2 10 mL In 1 VIAL None 2 65044-1438-3 30 mL In 1 VIAL None 3 65044-1438-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1450 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1450-2 10 mL In 1 VIAL None 2 65044-1450-3 30 mL In 1 VIAL None 3 65044-1450-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1453 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1453-2 10 mL In 1 VIAL None 2 65044-1453-3 30 mL In 1 VIAL None 3 65044-1453-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1540 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1540-2 10 mL In 1 VIAL None 2 65044-1540-3 30 mL In 1 VIAL None 3 65044-1540-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1543 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1543-2 10 mL In 1 VIAL None 2 65044-1543-3 30 mL In 1 VIAL None 3 65044-1543-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1544 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1544-2 10 mL In 1 VIAL None 2 65044-1544-3 30 mL In 1 VIAL None 3 65044-1544-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1546 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1546-2 10 mL In 1 VIAL None 2 65044-1546-3 30 mL In 1 VIAL None 3 65044-1546-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1564 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1564-2 10 mL In 1 VIAL None 2 65044-1564-3 30 mL In 1 VIAL None 3 65044-1564-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1660 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1660-2 10 mL In 1 VIAL None 2 65044-1660-3 30 mL In 1 VIAL None 3 65044-1660-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1662 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Liquidambar styraciflua pollen (Liquidambar styraciflua pollen) Liquidambar styraciflua pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1662-2 10 mL In 1 VIAL None 2 65044-1662-3 30 mL In 1 VIAL None 3 65044-1662-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1663 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1663-2 10 mL In 1 VIAL None 2 65044-1663-3 30 mL In 1 VIAL None 3 65044-1663-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1702 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1702-2 10 mL In 1 VIAL None 2 65044-1702-3 30 mL In 1 VIAL None 3 65044-1702-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1801 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1801-2 10 mL In 1 VIAL None 2 65044-1801-3 30 mL In 1 VIAL None 3 65044-1801-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1831 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1831-2 10 mL In 1 VIAL None 2 65044-1831-3 30 mL In 1 VIAL None 3 65044-1831-4 50 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, MELALEUCA (PUNK TREE) MELALEUCA QUINQUENERVIA  melaleuca (punk tree) melaleuca quinquenervia   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1873 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Melaleuca quinquenervia pollen (Melaleuca quinquenervia pollen) Melaleuca quinquenervia 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 65044-1873-2 10 mL In 1 VIAL None 2 65044-1873-3 30 mL In 1 VIAL None 3 65044-1873-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1876 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1876-2 10 mL In 1 VIAL None 2 65044-1876-3 30 mL In 1 VIAL None 3 65044-1876-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1909 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1909-2 10 mL In 1 VIAL None 2 65044-1909-3 30 mL In 1 VIAL None 3 65044-1909-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1912 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Morus alba pollen (Morus alba pollen) Morus alba pollen 0.1 g  in 1 mL Morus rubra pollen (Morus rubra pollen) Morus rubra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1912-2 10 mL In 1 VIAL None 2 65044-1912-3 30 mL In 1 VIAL None 3 65044-1912-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2035 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2035-2 10 mL In 1 VIAL None 2 65044-2035-3 30 mL In 1 VIAL None 3 65044-2035-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2038 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.1 g  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 0.1 g  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2038-2 10 mL In 1 VIAL None 2 65044-2038-3 30 mL In 1 VIAL None 3 65044-2038-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2039 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 20000 [PNU]  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 20000 [PNU]  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2039-2 10 mL In 1 VIAL None 2 65044-2039-3 30 mL In 1 VIAL None 3 65044-2039-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2014 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2014-2 10 mL In 1 VIAL None 2 65044-2014-3 30 mL In 1 VIAL None 3 65044-2014-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2050 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2050-2 10 mL In 1 VIAL None 2 65044-2050-3 30 mL In 1 VIAL None 3 65044-2050-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2053 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Olea europaea pollen (Olea europaea pollen) Olea europaea pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2053-2 10 mL In 1 VIAL None 2 65044-2053-3 30 mL In 1 VIAL None 3 65044-2053-4 50 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, PALM, QUEEN COCOS PLUMOSA  palm, queen cocos plumosa   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2074 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Syagrus romanzoffiana pollen (Syagrus romanzoffiana pollen) Syagrus romanzoffiana 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 65044-2074-2 10 mL In 1 VIAL None 2 65044-2074-3 30 mL In 1 VIAL None 3 65044-2074-4 50 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, PALO VERDE CERCIDIUM FLORIDUM  palo verde cercidium floridum   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2018 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cercidium floridum ssp. floridum pollen (Cercidium floridum ssp. floridum pollen) Cercidium floridum ssp. floridum 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 65044-2018-2 10 mL In 1 VIAL None 2 65044-2018-3 30 mL In 1 VIAL None 3 65044-2018-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2098 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2098-2 10 mL In 1 VIAL None 2 65044-2098-3 30 mL In 1 VIAL None 3 65044-2098-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2101 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2101-2 10 mL In 1 VIAL None 2 65044-2101-3 30 mL In 1 VIAL None 3 65044-2101-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2107 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2107-2 10 mL In 1 VIAL None 2 65044-2107-3 30 mL In 1 VIAL None 3 65044-2107-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2203 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2203-2 10 mL In 1 VIAL None 2 65044-2203-3 30 mL In 1 VIAL None 3 65044-2203-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2251 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2251-2 10 mL In 1 VIAL None 2 65044-2251-3 30 mL In 1 VIAL None 3 65044-2251-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2359 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2359-2 10 mL In 1 VIAL None 2 65044-2359-3 30 mL In 1 VIAL None 3 65044-2359-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2563 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2563-2 10 mL In 1 VIAL None 2 65044-2563-3 30 mL In 1 VIAL None 3 65044-2563-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2619 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2619-2 10 mL In 1 VIAL None 2 65044-2619-3 30 mL In 1 VIAL None 3 65044-2619-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2622 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 0.1 g  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 0.1 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.1 g  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.1 g  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 0.1 g  in 1 mL Ulmus Americana pollen (Ulmus Americana pollen) Ulmus Americana pollen 0.1 g  in 1 mL Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 0.1 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.1 g  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.1 g  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 0.1 g  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2622-2 10 mL In 1 VIAL None 2 65044-2622-3 30 mL In 1 VIAL None 3 65044-2622-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2624 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 20000 [PNU]  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 20000 [PNU]  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 20000 [PNU]  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 20000 [PNU]  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 20000 [PNU]  in 1 mL Ulmus Americana pollen (Ulmus Americana pollen) Ulmus Americana pollen 20000 [PNU]  in 1 mL Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 20000 [PNU]  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 20000 [PNU]  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 20000 [PNU]  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 20000 [PNU]  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2624-2 10 mL In 1 VIAL None 2 65044-2624-3 30 mL In 1 VIAL None 3 65044-2624-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2623 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 40000 [PNU]  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 40000 [PNU]  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 40000 [PNU]  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 40000 [PNU]  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 40000 [PNU]  in 1 mL Ulmus Americana pollen (Ulmus Americana pollen) Ulmus Americana pollen 40000 [PNU]  in 1 mL Carya ovata pollen (Carya ovata pollen) Carya ovata pollen 40000 [PNU]  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 40000 [PNU]  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 40000 [PNU]  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 40000 [PNU]  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2623-2 10 mL In 1 VIAL None 2 65044-2623-3 30 mL In 1 VIAL None 3 65044-2623-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2854 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2854-2 10 mL In 1 VIAL None 2 65044-2854-3 30 mL In 1 VIAL None 3 65044-2854-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2856 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 0.1 g  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 0.033 g  in 1 mL Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 0.033 g  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 0.033 g  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 0.033 g  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 0.033 g  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 0.033 g  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 0.1 g  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2856-2 10 mL In 1 VIAL None 2 65044-2856-3 30 mL In 1 VIAL None 3 65044-2856-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2855 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carya illinoinensis pollen (Carya illinoinensis pollen) Carya illinoinensis pollen 20000 [PNU]  in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 20000 [PNU]  in 1 mL Acer negundo pollen (Acer negundo pollen) Acer negundo pollen 20000 [PNU]  in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 20000 [PNU]  in 1 mL Quercus rubra pollen (Quercus rubra pollen) Quercus rubra pollen 20000 [PNU]  in 1 mL Quercus virginiana pollen (Quercus virginiana pollen) Quercus virginiana pollen 20000 [PNU]  in 1 mL Quercus alba pollen (Quercus alba pollen) Quercus alba pollen 20000 [PNU]  in 1 mL Platanus occidentalis pollen (Platanus occidentalis pollen) Platanus occidentalis pollen 20000 [PNU]  in 1 mL Salix nigra pollen (Salix nigra pollen) Salix nigra pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2855-2 10 mL In 1 VIAL None 2 65044-2855-3 30 mL In 1 VIAL None 3 65044-2855-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2863 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2863-2 10 mL In 1 VIAL None 2 65044-2863-3 30 mL In 1 VIAL None 3 65044-2863-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2861 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 0.1 g  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 0.1 g  in 1 mL Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 0.033 g  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 0.033 g  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 0.033 g  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.1 g  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 0.1 g  in 1 mL Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2861-2 10 mL In 1 VIAL None 2 65044-2861-3 30 mL In 1 VIAL None 3 65044-2861-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2862 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fraxinus americana pollen (Fraxinus americana pollen) Fraxinus americana pollen 20000 [PNU]  in 1 mL Fagus grandifolia pollen (Fagus grandifolia pollen) Fagus grandifolia pollen 20000 [PNU]  in 1 mL Betula papyrifera pollen (Betula papyrifera pollen) Betula papyrifera pollen 20000 [PNU]  in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 20000 [PNU]  in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 20000 [PNU]  in 1 mL Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 20000 [PNU]  in 1 mL Populus deltoides pollen (Populus deltoides pollen) Populus deltoides pollen 20000 [PNU]  in 1 mL Ulmus americana pollen (Ulmus americana pollen) Ulmus americana pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2862-2 10 mL In 1 VIAL None 2 65044-2862-3 30 mL In 1 VIAL None 3 65044-2862-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2599 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2599-2 10 mL In 1 VIAL None 2 65044-2599-3 30 mL In 1 VIAL None 3 65044-2599-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2626 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2626-2 10 mL In 1 VIAL None 2 65044-2626-3 30 mL In 1 VIAL None 3 65044-2626-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2629 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Juglans nigra pollen (Juglans nigra pollen) Juglans nigra pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2629-2 10 mL In 1 VIAL None 2 65044-2629-3 30 mL In 1 VIAL None 3 65044-2629-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2677 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2677-2 10 mL In 1 VIAL None 2 65044-2677-3 30 mL In 1 VIAL None 3 65044-2677-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1405 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1405-2 10 mL In 1 VIAL None 2 65044-1405-3 30 mL In 1 VIAL None 3 65044-1405-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1408 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1408-2 10 mL In 1 VIAL None 2 65044-1408-3 30 mL In 1 VIAL None 3 65044-1408-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1409 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1409-2 10 mL In 1 VIAL None 2 65044-1409-3 30 mL In 1 VIAL None 3 65044-1409-4 50 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, DOG FENNEL, EASTERN EUPATORIUM CAPILLIFOLIUM  dog fennel, eastern eupatorium capillifolium   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2057 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Eupatorium capillifolium pollen (Eupatorium capillifolium pollen) Eupatorium capillifolium 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 65044-2057-2 10 mL In 1 VIAL None 2 65044-2057-3 30 mL In 1 VIAL None 3 65044-2057-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1630 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1630-2 10 mL In 1 VIAL None 2 65044-1630-3 30 mL In 1 VIAL None 3 65044-1630-4 50 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, LAMBS QUARTERS CHENOPODIUM ALBUM  lambs quarters chenopodium album   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1786 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1786-2 10 mL In 1 VIAL None 2 65044-1786-3 30 mL In 1 VIAL None 3 65044-1786-4 50 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, LAMBS QUARTERS CHENOPODIUM ALBUM  lambs quarters chenopodium album   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1789 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1789-2 10 mL In 1 VIAL None 2 65044-1789-3 30 mL In 1 VIAL None 3 65044-1789-4 50 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, LAMBS QUARTERS CHENOPODIUM ALBUM  lambs quarters chenopodium album   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1790 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1790-2 10 mL In 1 VIAL None 2 65044-1790-3 30 mL In 1 VIAL None 3 65044-1790-4 50 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, LAMBS QUARTERS CHENOPODIUM ALBUM  lambs quarters chenopodium album   injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1791 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1791-2 10 mL In 1 VIAL None 2 65044-1791-3 30 mL In 1 VIAL None 3 65044-1791-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1945 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1945-2 10 mL In 1 VIAL None 2 65044-1945-3 30 mL In 1 VIAL None 3 65044-1945-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1947 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urtica dioica pollen (Urtica dioica pollen) Urtica dioica pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1947-2 10 mL In 1 VIAL None 2 65044-1947-3 30 mL In 1 VIAL None 3 65044-1947-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2125 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2125-2 10 mL In 1 VIAL None 2 65044-2125-3 30 mL In 1 VIAL None 3 65044-2125-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2212 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2212-2 10 mL In 1 VIAL None 2 65044-2212-3 30 mL In 1 VIAL None 3 65044-2212-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2215 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Plantago lanceolata pollen (Plantago lanceolata pollen) Plantago lanceolata pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2215-2 10 mL In 1 VIAL None 2 65044-2215-3 30 mL In 1 VIAL None 3 65044-2215-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2217 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Plantago lanceolata pollen (Plantago lanceolata pollen) Plantago lanceolata pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2217-2 10 mL In 1 VIAL None 2 65044-2217-3 30 mL In 1 VIAL None 3 65044-2217-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2216 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Plantago lanceolata pollen (Plantago lanceolata pollen) Plantago lanceolata pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2216-2 10 mL In 1 VIAL None 2 65044-2216-3 30 mL In 1 VIAL None 3 65044-2216-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2293 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2293-2 10 mL In 1 VIAL None 2 65044-2293-3 30 mL In 1 VIAL None 3 65044-2293-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2296 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ambrosia trifida pollen (Ambrosia trifida pollen) Ambrosia trifida pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2296-2 10 mL In 1 VIAL None 2 65044-2296-3 30 mL In 1 VIAL None 3 65044-2296-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2308 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2308-2 10 mL In 1 VIAL None 2 65044-2308-3 30 mL In 1 VIAL None 3 65044-2308-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2311 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ambrosia psilostachya pollen (Ambrosia psilostachya pollen) Ambrosia psilostachya pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2311-2 10 mL In 1 VIAL None 2 65044-2311-3 30 mL In 1 VIAL None 3 65044-2311-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2362 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2362-2 10 mL In 1 VIAL None 2 65044-2362-3 30 mL In 1 VIAL None 3 65044-2362-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2413 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2413-2 10 mL In 1 VIAL None 2 65044-2413-3 30 mL In 1 VIAL None 3 65044-2413-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2416 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Artemisia vulgaris pollen (Artemisia vulgaris pollen) Artemisia vulgaris pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2416-2 10 mL In 1 VIAL None 2 65044-2416-3 30 mL In 1 VIAL None 3 65044-2416-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2417 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Artemisia vulgaris pollen (Artemisia vulgaris pollen) Artemisia vulgaris pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2417-2 10 mL In 1 VIAL None 2 65044-2417-3 30 mL In 1 VIAL None 3 65044-2417-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2482 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2482-2 10 mL In 1 VIAL None 2 65044-2482-3 30 mL In 1 VIAL None 3 65044-2482-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2485 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Atriplex canescens pollen (Atriplex canescens pollen) Atriplex canescens pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2485-2 10 mL In 1 VIAL None 2 65044-2485-3 30 mL In 1 VIAL None 3 65044-2485-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2487 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cytisus scoparius Flowering Top (Cytisus scoparius Flowering Top) Cytisus scoparius Flowering Top 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 65044-2487-2 10 mL In 1 VIAL None 2 65044-2487-3 30 mL In 1 VIAL None 3 65044-2487-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2506 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2506-2 10 mL In 1 VIAL None 2 65044-2506-3 30 mL In 1 VIAL None 3 65044-2506-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2508 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2508-2 10 mL In 1 VIAL None 2 65044-2508-3 30 mL In 1 VIAL None 3 65044-2508-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1297 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1297-2 10 mL In 1 VIAL None 2 65044-1297-3 30 mL In 1 VIAL None 3 65044-1297-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1300 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1300-2 10 mL In 1 VIAL None 2 65044-1300-3 30 mL In 1 VIAL None 3 65044-1300-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1303 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Amaranthus palmeri pollen (Amaranthus palmeri pollen) Amaranthus palmeri pollen 0.1 g  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1303-2 10 mL In 1 VIAL None 2 65044-1303-3 30 mL In 1 VIAL None 3 65044-1303-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1516 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1516-2 10 mL In 1 VIAL None 2 65044-1516-3 30 mL In 1 VIAL None 3 65044-1516-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1519 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 0.1 g  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1519-2 10 mL In 1 VIAL None 2 65044-1519-3 30 mL In 1 VIAL None 3 65044-1519-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1520 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 20000 [PNU]  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1520-2 10 mL In 1 VIAL None 2 65044-1520-3 30 mL In 1 VIAL None 3 65044-1520-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2320 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2320-2 10 mL In 1 VIAL None 2 65044-2320-3 30 mL In 1 VIAL None 3 65044-2320-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1780 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1780-2 10 mL In 1 VIAL None 2 65044-1780-3 30 mL In 1 VIAL None 3 65044-1780-5 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1783 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Kochia scoparia pollen (Kochia scoparia pollen) Kochia scoparia pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1783-2 10 mL In 1 VIAL None 2 65044-1783-3 30 mL In 1 VIAL None 3 65044-1783-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1858 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-1858-2 10 mL In 1 VIAL None 2 65044-1858-3 30 mL In 1 VIAL None 3 65044-1858-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-1861 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iva axillaris pollen (Iva axillaris pollen) Iva axillaris pollen 0.1 g  in 1 mL Iva annua var. annua pollen (Iva annua var. annua pollen) Iva annua var. annua pollen 0.1 g  in 1 mL Iva xanthifolia pollen (Iva xanthifolia pollen) Iva xanthifolia pollen 0.1 g  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-1861-2 10 mL In 1 VIAL None 2 65044-1861-3 30 mL In 1 VIAL None 3 65044-1861-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2634 Route of Administration PERCUTANEOUS, SUBCUTANEOUS 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 65044-2634-2 10 mL In 1 VIAL None 2 65044-2634-3 30 mL In 1 VIAL None 3 65044-2634-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2632 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 0.1 g  in 1 mL Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 0.1 g  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 0.1 g  in 1 mL 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 phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2632-2 10 mL In 1 VIAL None 2 65044-2632-3 30 mL In 1 VIAL None 3 65044-2632-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2635 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 20000 [PNU]  in 1 mL Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 20000 [PNU]  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 20000 [PNU]  in 1 mL Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 20000 [PNU]  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 20000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2635-2 10 mL In 1 VIAL None 2 65044-2635-3 30 mL In 1 VIAL None 3 65044-2635-4 50 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 NON-STANDARDIZED ALLERGENIC NDC Product Code (Source) 65044-2633 Route of Administration PERCUTANEOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Xanthium strumarium pollen (Xanthium strumarium pollen) Xanthium strumarium pollen 40000 [PNU]  in 1 mL Chenopodium album pollen (Chenopodium album pollen) Chenopodium album pollen 40000 [PNU]  in 1 mL Amaranthus retroflexus pollen (Amaranthus retroflexus pollen) Amaranthus retroflexus pollen 40000 [PNU]  in 1 mL Rumex crispus pollen (Rumex crispus pollen) Rumex crispus pollen 40000 [PNU]  in 1 mL Rumex acetosella pollen (Rumex acetosella pollen) Rumex acetosella pollen 40000 [PNU]  in 1 mL

Inactive Ingredients Ingredient Name Strength phenol   sodium chloride   sodium bicarbonate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65044-2633-2 10 mL In 1 VIAL None 2 65044-2633-3 30 mL In 1 VIAL None 3 65044-2633-4 50 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 LLC		069263643	manufacture

Revised: 12/2009Hollister Stier Laboratories LLC