Animal Allergens, AP Horse Hair and Dander

Jubilant HollisterStier LLC
Jubilant HollisterStier LLC

INSTRUCTIONS ALLERGENIC EXTRACTS FOR INTRADERMAL TESTING

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNINGS
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DESCRIPTION
• CLINICAL PHARMACOLOGY
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER INDICATIONS AND USAGE
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • 1. General
  • 2. Information for Patients
  • 3. Carcinogenesis, Mutagensis, Impairment of Fertility
  • 4. Pregnancy
  • 5. Nursing Mothers
  • 6. Drug Interactions
  • 7. Geriatric Use
  • 8. Pediatric Use
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ADVERSE REACTIONS
• OVERDOSE SECTION
• ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DOSAGE AND ADMINISTRATION
  • 5. Geriatric Use
  • 6. Pediatric Use
• HOW SUPPLIED
• STORAGE
• LIMITED WARRANTY
• REFERENCES

FULL PRESCRIBING INFORMATION

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DESCRIPTION

• Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, AP™ (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP™ extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution.
• 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, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.
• Allergy Units per mL (AU/mL). The potency of standardized AP™ and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.
• Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID₅₀EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects.
• Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.
  

CLINICAL PHARMACOLOGY

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

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER INDICATIONS AND USAGE

Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15

In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY.

Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER CONTRAINDICATIONS

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

WARNINGS

Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.

PRECAUTIONS

1. General

ADVERSE REACTION

2. Information for Patients

Patients should be instructed in the recognition of adverse reactions to diagnostic testing. Patients should be made to understand the importance of a 30 to 45 minute observation period and be warned to return to the office promptly if symptoms occur after leaving.

3. Carcinogenesis, Mutagensis, 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.

4. Pregnancy

4,5 Pregnancy Category C. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.

5. Nursing Mothers

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

6. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.10Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. 10, 11 Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.12Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites. 13

7. Geriatric Use

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

8. Pediatric Use

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

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ADVERSE REACTIONS

1. Local Reactions
Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions.

2. Systemic Reactions
With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent in sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.7, 8 It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is a possibility. Other possible systemic reaction symptoms, in varying degrees of severity, are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection, if tests are performed on the arms, and inject the 1:1000 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:

Ref. J. Allergy Clin. Immunol. 77 (2): 271-273, 1986

3. Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier 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

ADVERSE REACTION

ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER DOSAGE AND ADMINISTRATION

1. General


2. Intradermal Testing Methods


3. Use of Antigen Mixes


4. Reading Skin Test Reactions

Standardized Products
Mites

AU/mL that Elicited ∑E = 50 mm
Allergen	Number of Persons	Mean	2 Std. Dev. Range
D. farinae	12	0.0609	0.0015-2.6016
D. pteronyssinus	12	0.333	0.0003-4.0077

Patients with a negative scratch, prick or puncture test:
Patients tested only by the intradermal method
Cat Hair and Cat Pelt_50
50

Intradermal Tests should be done only on patients with a negative prick or puncture test

Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed:

5. Geriatric Use

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

6. Pediatric Use

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

Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

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

^a or with pseudopods

^b or with many pseudopods

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

HOW SUPPLIED

Most allergens are available in multiple dose 5 mL vials at PNU, w/v, some mixes as Concentrate, Standardized Mite products at AU/mL (30 AU/mL and 300 AU/mL each species), or Standardized Grass products at BAU/mL [100 BAU/mL and 1,000 BAU/mL (Bermuda 100 BAU/mL only)]. Product labels state vials are for intradermal testing and list strengths.

STORAGE

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

In Vivo





Ambrosia artemisiifolia

Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4857 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS HAIR EQUUS CABALLUS HAIR 0.0005 g EQUUS CABALLUS DANDER Equus caballus dander 0.0005 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4857-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1978-01-30

Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4813 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS HAIR BOS TAURUS HAIR 0.0005 g BOS TAURUS DANDER Bos taurus dander 0.0005 g Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4813-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1978-01-30

Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4351 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER GALLUS GALLUS FEATHER 200 [PNU] ANAS PLATYRHYNCHOS FEATHER ANAS PLATYRHYNCHOS FEATHER 200 [PNU] ANSER ANSER FEATHER ANAS PLATYRHYNCHOS FEATHER 200 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4351-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4706 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4706-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1972-08-17

Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-4702 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-4702-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6586 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 500 [PNU] BLATELLA GERMANICA BLATELLA GERMANICA 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6586-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-6516 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Solenopsis richteri Solenopsis richteri 500 [PNU] SOLENOPSIS INVICTA Solenopsis invicta 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-6516-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5138 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 1000 [PNU] ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 1000 [PNU] Aspergillus nidulans Aspergillus nidulans 1000 [PNU] ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 1000 [PNU] ASPERGILLUS TERREUS Aspergillus terreus 1000 [PNU] FUSARIUM OXYSPORUM VASINFECTUM Fusarium oxysporum vasinfectum 1000 [PNU] Dendryphiella vinosa Dendryphiella vinosa 1000 [PNU] CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU] MUCOR RACEMOSUS mucor racemosus 1000 [PNU] Penicillium digitatum Penicillium digitatum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU] Clonostachys rosea f. rosea Clonostachys rosea f. rosea 1000 [PNU] PHOMA EXIGUA VAR. EXIGUA Phoma exigua var. exigua 1000 [PNU] AUREOBASIDIUM PULLULANS VAR. PULLUTANS AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU] RHIZOPUS STOLONIFER RHIZOPUS STOLONIFER 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5138-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5001 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 1000 [PNU] ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 1000 [PNU] Aspergillus nidulans Aspergillus nidulans 1000 [PNU] ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 1000 [PNU] ASPERGILLUS TERREUS Aspergillus terreus 1000 [PNU] CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU] Penicillium digitatum Penicillium digitatum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU] Clonostachys rosea f. rosea Clonostachys rosea f. rosea 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5001-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5286 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON TONSURANS Trichophyton tonsurans 1000 [PNU] TRICHOPHYTON RUBRUM Trichophyton rubrum 1000 [PNU] TRICHOPHYTON MENTAGROPHYTES Trichophyton mentagrophytes 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5286-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5170 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillium digitatum Penicillium digitatum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM EXPANSUM Penicillium expansum 1000 [PNU] PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU] Clonostachys rosea f. rosea Clonostachys rosea f. rosea 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5170-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5010 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5010-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5022 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5022-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5054 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS candida albicans 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5054-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5058 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM Acremonium strictum 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5058-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5078 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER Cochliobolus spicifer 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5078-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5102 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM EPICOCCUM NIGRUM 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5102-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5114 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM Fusarium oxysporum vasinfectum 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5114-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5126 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dendryphiella vinosa Dendryphiella vinosa 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5126-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5130 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5130-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5146 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS mucor racemosus 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5146-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5210 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5210-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5222 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA Phoma exigua var. exigua 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5222-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5234 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5234-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5231 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER RHIZOPUS STOLONIFER 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5231-1 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-5266 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLEOSPORA TARDA PLEOSPORA TARDA 1000 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-5266-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1083 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN PASPALUM NOTATUM POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1083-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1746 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN SORGHUM HALEPENSE POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1746-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1008 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA LONGIFOLIA POLLEN Acacia longifolia pollen 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1008-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1020 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN ALNUS RUBRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1020-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1062 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN FRAXINUS AMERICANA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1062-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1170 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA PAPYRIFERA POLLEN BETULA PAPYRIFERA POLLEN 500 [PNU] BETULA PENDULA POLLEN Betula pendula pollen 500 [PNU] BETULA NIGRA POLLEN BETULA NIGRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1170-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1215 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN ACER NEGUNDO POLLEN 500 [PNU] ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 500 [PNU] ACER RUBRUM POLLEN ACER RUBRUM POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1215-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1338 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN JUNIPERUS ASHEI POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1338-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1341 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN JUNIPERUS VIRGINIANA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1341-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1437 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN POPULUS DELTOIDES POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1437-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1542 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN ULMUS AMERICANA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1542-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1548 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ulmus parvifolia pollen Ulmus parvifolia pollen 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1548-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1665 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN CELTIS OCCIDENTALIS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1665-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1833 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1833-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1878 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN PROSOPIS JULIFLORA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1878-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1911 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN MORUS ALBA POLLEN 500 [PNU] MORUS RUBRA POLLEN MORUS RUBRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1911-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2037 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN QUERCUS RUBRA POLLEN 500 [PNU] QUERCUS VIRGINIANA POLLEN QUERCUS VIRGINIANA POLLEN 500 [PNU] QUERCUS ALBA POLLEN QUERCUS ALBA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2037-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2016 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN QUERCUS RUBRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2016-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2052 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN OLEA EUROPAEA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2052-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2100 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN CARYA ILLINOINENSIS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2100-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Russian Olive Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2361 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELAEAGNUS ANGUSTIFOLIA POLLEN ELAEAGNUS ANGUSTIFOLIA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2361-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Sycamore, American (Eastern) Platanus occidentallis Sycamore, American (Eastern) Platanus occidentallis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2565 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN PLATANUS OCCIDENTALIS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2565-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2621 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN FRAXINUS AMERICANA POLLEN 500 [PNU] FAGUS GRANDIFOLIA POLLEN FAGUS GRANDIFOLIA POLLEN 500 [PNU] BETULA NIGRA POLLEN BETULA NIGRA POLLEN 500 [PNU] JUGLANS NIGRA POLLEN JUGLANS NIGRA POLLEN 500 [PNU] POPULUS DELTOIDES POLLEN POPULUS DELTOIDES POLLEN 500 [PNU] ULMUS AMERICANA POLLEN ULMUS AMERICANA POLLEN 500 [PNU] CARYA OVATA POLLEN CARYA OVATA POLLEN 500 [PNU] ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 500 [PNU] QUERCUS RUBRA POLLEN QUERCUS RUBRA POLLEN 500 [PNU] PLATANUS OCCIDENTALIS POLLEN PLATANUS OCCIDENTALIS POLLEN 500 [PNU] SALIX NIGRA POLLEN SALIX NIGRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2621-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2857 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN CARYA ILLINOINENSIS POLLEN 500 [PNU] ACER SACCHARUM POLLEN ACER SACCHARUM POLLEN 500 [PNU] ACER NEGUNDO POLLEN ACER NEGUNDO POLLEN 500 [PNU] ACER RUBRUM POLLEN ACER RUBRUM POLLEN 500 [PNU] QUERCUS RUBRA POLLEN QUERCUS RUBRA POLLEN 500 [PNU] QUERCUS VIRGINIANA POLLEN QUERCUS VIRGINIANA POLLEN 500 [PNU] QUERCUS ALBA POLLEN QUERCUS ALBA POLLEN 500 [PNU] PLATANUS OCCIDENTALIS POLLEN PLATANUS OCCIDENTALIS POLLEN 500 [PNU] SALIX NIGRA POLLEN SALIX NIGRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2857-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2860 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN FRAXINUS AMERICANA POLLEN 500 [PNU] FAGUS GRANDIFOLIA POLLEN FAGUS GRANDIFOLIA POLLEN 500 [PNU] BETULA PAPYRIFERA POLLEN BETULA PAPYRIFERA POLLEN 500 [PNU] BETULA NIGRA POLLEN BETULA NIGRA POLLEN 500 [PNU] BETULA PENDULA POLLEN Betula pendula pollen 500 [PNU] JUGLANS NIGRA POLLEN JUGLANS NIGRA POLLEN 500 [PNU] POPULUS DELTOIDES POLLEN POPULUS DELTOIDES POLLEN 500 [PNU] ULMUS AMERICANA POLLEN ULMUS AMERICANA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2860-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2628 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN JUGLANS NIGRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2628-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2679 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN SALIX NIGRA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2679-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1407 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN XANTHIUM STRUMARIUM POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1407-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1632 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN SOLIDAGO CANADENSIS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1632-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Lamb Quarters Chenopodium album Lamb Quarters Chenopodium album INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1788 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN CHENOPODIUM ALBUM POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1788-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2127 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN AMARANTHUS RETROFLEXUS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2127-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2214 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN PLANTAGO LANCEOLATA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2214-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2295 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN AMBROSIA TRIFIDA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2295-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2310 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN AMBROSIA PSILOSTACHYA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2310-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2364 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN SALSOLA KALI POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2364-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2415 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN ARTEMISIA VULGARIS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2415-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds and Garden Plants, Scale, Wing (Shad) Atriplex canescens Scale, Wing (Shad) Atriplex canescens INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2484 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CANESCENS POLLEN ATRIPLEX CANESCENS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2484-1 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1302 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN AMARANTHUS PALMERI POLLEN 500 [PNU] AMARANTHUS RETROFLEXUS POLLEN AMARANTHUS RETROFLEXUS POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1302-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1518 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN RUMEX CRISPUS POLLEN 500 [PNU] RUMEX ACETOSELLA POLLEN RUMEX ACETOSELLA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1518-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2319 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN AMBROSIA TRIFIDA POLLEN 500 [PNU] AMBROSIA ARTEMISIIFOLIA POLLEN AMBROSIA ARTEMISIIFOLIA POLLEN 500 [PNU] AMBROSIA PSILOSTACHYA POLLEN AMBROSIA PSILOSTACHYA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2319-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1782 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN BASSIA SCOPARIA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1782-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-1860 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA AXILLARIS POLLEN IVA AXILLARIS POLLEN 500 [PNU] IVA ANNUA POLLEN IVA ANNUA POLLEN 500 [PNU] CYCLACHAENA XANTHIFOLIA POLLEN CYCLACHAENA XANTHIFOLIA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-1860-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19

Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:65044-2631 Route of Administration INTRADERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN XANTHIUM STRUMARIUM POLLEN 500 [PNU] CHENOPODIUM ALBUM POLLEN CHENOPODIUM ALBUM POLLEN 500 [PNU] AMARANTHUS RETROFLEXUS POLLEN AMARANTHUS RETROFLEXUS POLLEN 500 [PNU] RUMEX CRISPUS POLLEN RUMEX CRISPUS POLLEN 500 [PNU] RUMEX ACETOSELLA POLLEN RUMEX ACETOSELLA POLLEN 500 [PNU] Inactive Ingredients Ingredient Name Strength PHENOL SODIUM CHLORIDE SODIUM BICARBONATE GLYCERIN Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65044-2631-5 5 in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 1941-04-19