美国FDA生物制品紫皮书数据库（U.S. FDA Purple Book: Database of Licensed Biological Products）- 药物在线

商品名	申请号	产品号	BLA类型	非专利名称	剂型	给药途径	规格/剂量	产品形式	批准日期	申请人	市场状态	许可证状态
N/A	103870	2	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Intradermal	30AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103870	3	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Subcutaneous	30,000AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103870	4	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Intradermal	300AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103870	5	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Percutaneous	30,000AU/ML	Dropper Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103871	1	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Subcutaneous	10,000AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103871	2	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Intradermal	30AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103871	3	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Subcutaneous	30,000AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103871	4	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Intradermal	300AU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103871	5	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Percutaneous	30,000AU/ML	Dropper Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103872	1	351(a)	Pollens - Grasses, Bermuda Grass Cynodon dactylon	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
N/A	103872	2	351(a)	Pollens - Grasses, Bermuda Grass Cynodon dactylon	Injection	Intradermal	100BAU/ML	Multi-Dose Vial	1924/03/13	Jubilant HollisterStier LLC	Rx	Licensed
Infasurf	020521	3	351(a)	calfactant	Suspension	Intratracheal	420MG/12ML (35MG/ML)	Single-Dose Vial		ONY Biotech Inc.	Disc	Licensed
Aranesp	103951	49	351(a)	darbepoetin alpha	Injection	Intravenous, Subcutaneous	10MCG/0.4ML	Pre-Filled Syringe		Amgen Inc.	Rx	Licensed
Epogen/Procrit	103234	2	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	20,000UNITS/2ML (10,000UNITS/ML)	Multi-Dose Vial		Amgen Inc.	Rx	Licensed
Epogen/Procrit	103234	3	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	20,000UNITS/ML	Multi-Dose Vial		Amgen Inc.	Rx	Licensed
Procrit	103234	6	351(a)	epoetin alfa	Injection	Intravenous, Subcutaneous	40,000UNITS/ML	Single-Dose Vial		Amgen Inc.	Rx	Licensed
Enbrel	103795	6	351(a)	etanercept	Injection	Subcutaneous	50MG/ML	Autoinjector		Immunex Corporation	Rx	Licensed
Intron A	103132	5	351(a)	interferon alfa-2b	For Injection	Intramuscular, Intravenous, Subcutaneous	18MIU	Multi-Dose Vial		Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
Intron A	103132	6	351(a)	interferon alfa-2b	For Injection	Intramuscular, Intravenous, Subcutaneous	50MIU	Single-Dose Vial		Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
Intron A	103132	7	351(a)	interferon alfa-2b	Injection	Subcutaneous, Intramuscular	3MIU	Single-Dose Vial		Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked

药品商品名或专利药名Proprietary (Brand) Name
药品通用名或非专利名称Nonproprietary (Proper) Name
药品申请号BLA Number
产品号Product Number
剂型Dosage Form
给药途径Route of Administration
产品形式Product Presentation
药品规格或剂量Strength
药品注册申请人Applicant
参考产品非专利名称Reference Product Proper Name
参考产品专利名称Reference Product Proprietary Name
BLA类型BLA Type
药品的市场状态Marketing Status
许可证号License Number
许可证状态Licensure
产品批准日期Approval Date	-