splendid [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 is Animal Allergens Injection 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 The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2 to 8 C, and kept at this temperature range during office use. LIMITED WARRANTY A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company s headquarters. The prescriber and user of this product must accept the terms hereof. REFERENCES 1. Middleton, Elliott, Jr., C. E. Reed and E. F. Ellis (Eds.) Allergy Principles and Practice. Vol. 1, C. V. Mosby, 1978. 2. Sheldon, J. M., R. C. Lovell, and K. P. Mathews. A Manual of Clinical Allergy. W. B. Saunders, 1967. 3. Tuft, L. and H. L. Mueller, Allergy in Children. W. B. Saunders, 1979. 4. DuBuske, L.M., C.J. Ling and A.L. Sheffer. Special problems regarding allergen immunotherapy. Immunol. Allergy. Clin. North Am. (USA). 12(1): 145-175, 1992. 5. Weinstein, A. M., D. B. Dubin, W. K. Podleski, L. L. Spector and R. S. Farr. Asthma and pregnancy. JAMA 134(11): 1161-1165, 1979. 6. Jacobs, Robert L., Goeffrey W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol. 68(2): 125-127, August 1981. 7. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79(4): 660-677, 1987. 8. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989. 9. Norman, P. S., L. M. Lichtenstein, and K. Ishizaka. Diagnostic tests in ragweed hay fever. J. Allergy Clin. Immunol. 52(4): 212-224, 1973. 10. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988. 11. 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. 12. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988. 13. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987. 14. Turkeltaub, Paul C., C. Rastogi Suresh, Harold Baer. Office of Biologics Research and Review skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method (Intradermal Dilution for 50 mm Sum of Erythema Determines the Allergy Unit). Methods of the Allergenic Products Branch Office of Biologics Research and Review, FDA, Bethesda, MD 20892. Revised May 9, 1986. 15. Food and Drug Administration. Bilogical products; Allergenic extracts classified in Category IIIB; Final order; Revocation of licenses. Federal Register. 59(220):59228ff, November 16, 1994. ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER ap horse hair and dander injection, solution Product Information Product Type NON-STANDARDIZED ALLERGENIC 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) Equus caballus hair 0.0005 g in 1 mL Equus caballus dander (Equus caballus dander) Equus caballus dander 0.0005 g in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-4857-5 5 mL in 1 VIAL 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 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) Bos taurus hair 0.0005 g in 1 mL Bos taurus dander (Bos taurus dander) Bos taurus dander 0.0005 g in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-4813-5 5 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 01/30/1978 ANIMAL ALLERGENS, FEATHER MIX feather mix injection, solution Product Information Product Type NON-STANDARDIZED ALLERGENIC 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) Gallus gallus Feather 200 [PNU] in 1 mL Anas platyrhynchos feather (Anas platyrhynchos feather) Anas platyrhynchos feather 200 [PNU] in 1 mL Anser anser feather (Anser anser feather) Anser anser feather 200 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-4351-5 5 mL in 1 VIAL 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 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) House Dust 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-4706-5 5 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103888 08/17/1972 DUST, HOUSE MIXTURE dust, house mixture injection, solution Product Information Product Type NON-STANDARDIZED ALLERGENIC 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) House Dust 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-4702-5 5 mL in 1 VIAL 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 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) Periplaneta americana 500 [PNU] in 1 mL Blatella germanica (Blatella germanica) Blatella germanica 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-6586-5 5 mL in 1 VIAL 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 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) Solenopsis richteri 500 [PNU] in 1 mL Solenopsis invicta (Solenopsis invicta) Solenopsis invicta 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-6516-5 5 mL in 1 VIAL 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 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) Alternaria alternata 1000 [PNU] in 1 mL Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 1000 [PNU] in 1 mL Emericella nidulans (Emericella nidulans) Emericella nidulans 1000 [PNU] in 1 mL Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 1000 [PNU] in 1 mL Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 1000 [PNU] in 1 mL Fusarium oxysporum vasinfectum (Fusarium oxysporum vasinfectum) Fusarium oxysporum vasinfectum 1000 [PNU] in 1 mL Dendryphiella vinosa (Dendryphiella vinosa) Dendryphiella vinosa 1000 [PNU] in 1 mL Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 1000 [PNU] in 1 mL Mucor racemosus (Mucor racemosus) Mucor racemosus 1000 [PNU] in 1 mL Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU] in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU] in 1 mL Phoma exigua var. exigua (Phoma exigua var. exigua) Phoma exigua var. exigua 1000 [PNU] in 1 mL Aureobasidium pullulans var. pullutans (Aureobasidium pullulans var. pullutans) Aureobasidium pullulans var. pullutans 1000 [PNU] in 1 mL Rhizopus stolonifer (Rhizopus stolonifer) Rhizopus stolonifer 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5138-5 5 mL in 1 VIAL 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 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) Alternaria alternata 1000 [PNU] in 1 mL Aspergillus fumigatus (Aspergillus fumigatus) Aspergillus fumigatus 1000 [PNU] in 1 mL Emericella nidulans (Emericella nidulans) Emericella nidulans 1000 [PNU] in 1 mL Aspergillus niger var. niger (Aspergillus niger var. niger) Aspergillus niger var. niger 1000 [PNU] in 1 mL Aspergillus terreus (Aspergillus terreus) Aspergillus terreus 1000 [PNU] in 1 mL Cladosporium cladosporioides (Cladosporium cladosporioides) Cladosporium cladosporioides 1000 [PNU] in 1 mL Penicillium digitatum (Penicillium digitatum) Penicillium digitatum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU] in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5001-5 5 mL in 1 VIAL 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 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) Trichophyton tonsurans 1000 [PNU] in 1 mL Trichophyton rubrum (Trichophyton rubrum) Trichophyton rubrum 1000 [PNU] in 1 mL Trichophyton mentagrophytes (Trichophyton mentagrophytes) Trichophyton mentagrophytes 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5286-5 5 mL in 1 VIAL 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 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) Penicillium digitatum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium expansum (Penicillium expansum) Penicillium expansum 1000 [PNU] in 1 mL Penicillium chrysogenum var. chrysogenum (Penicillium chrysogenum var. chrysogenum) Penicillium chrysogenum var. chrysogenum 1000 [PNU] in 1 mL Clonostachys rosea f. rosea (Clonostachys rosea f. rosea) Clonostachys rosea f. rosea 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5170-5 5 mL in 1 VIAL 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 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) Alternaria alternata 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5010-5 5 mL in 1 VIAL 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 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) Aspergillus fumigatus 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5022-5 5 mL in 1 VIAL 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 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) Candida albicans 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5054-5 5 mL in 1 VIAL 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 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) Acremonium strictum 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5058-5 5 mL in 1 VIAL 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 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) Cochliobolus spicifer 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5078-5 5 mL in 1 VIAL 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 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) Epicoccum nigrum 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5102-5 5 mL in 1 VIAL 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 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) Fusarium oxysporum vasinfectum 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5114-5 5 mL in 1 VIAL 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 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) Dendryphiella vinosa 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5126-5 5 mL in 1 VIAL 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 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) Cladosporium cladosporioides 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5130-5 5 mL in 1 VIAL 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 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) Mucor racemosus 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5146-5 5 mL in 1 VIAL 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 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) Penicillium chrysogenum var. chrysogenum 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5210-5 5 mL in 1 VIAL 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 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) Phoma exigua var. exigua 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5222-5 5 mL in 1 VIAL 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 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) Aureobasidium pullulans var. pullutans 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5234-5 5 mL in 1 VIAL 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 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) Rhizopus stolonifer 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5231-1 5 mL in 1 VIAL 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 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) Pleospora tarda 1000 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-5266-5 5 mL in 1 VIAL 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 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) Paspalum notatum pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1083-5 5 mL in 1 VIAL 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 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) Sorghum halepense pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1746-5 5 mL in 1 VIAL 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 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) Acacia longifolia pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1008-5 5 mL in 1 VIAL 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 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) Alnus rubra pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1020-5 5 mL in 1 VIAL 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 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) Fraxinus americana pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1062-5 5 mL in 1 VIAL 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 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) Betula papyrifera pollen 500 [PNU] in 1 mL Betula pendula pollen (Betula pendula pollen) Betula pendula pollen 500 [PNU] in 1 mL Betula nigra pollen (Betula nigra pollen) Betula nigra pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1170-5 5 mL in 1 VIAL 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 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) Acer negundo pollen 500 [PNU] in 1 mL Acer saccharum pollen (Acer saccharum pollen) Acer saccharum pollen 500 [PNU] in 1 mL Acer rubrum pollen (Acer rubrum pollen) Acer rubrum pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength phenol sodium chloride sodium bicarbonate glycerin Packaging # Item Code Package Description 1 NDC:65044-1215-5 5 mL in 1 VIAL 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 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) Juniperus ashei pollen 500 [PNU] in 1 mL Inactive Ingredients Ingredient Name Strength p a prolonged
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