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	参考产品非专利名称	参考产品专利名称
Neumega	103694	001	351(a)	oprelvekin	For Injection	Subcutaneous	5MG	Single-Dose Vial	1997/11/25	Wyeth Pharmaceuticals Inc.	Disc	Voluntarily Revoked	N/A	N/A
Rabavert	103334	001	351(a)	Rabies Vaccine	For Injection	Intramuscular	2.5IU	Single-Dose Vial	1997/10/20	Bavarian Nordic A/S	Rx	Licensed		N/A
Infergen	103663	001	351(a)	interferon alfacon-1	Injection	Subcutaneous	9MCG/0.3ML (30MCG/ML)	Single-Dose Vial	1997/10/06	Kadmon Pharmaceuticals LLC	Disc	Voluntarily Revoked	N/A	N/A
Gonal-f	020378	001	351(a)	follitropin alfa	For Injection	Subcutaneous	75IU	Ampule	1997/09/29	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Gonal-f	020378	002	351(a)	follitropin alfa	For Injection	Subcutaneous	150IU	Ampule	1997/09/29	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Follistim	020582	001	351(a)	follitropin beta	For Injection	Subcutaneous, Intramuscular	75IU	Single-Dose Vial	1997/09/29	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Follistim	020582	002	351(a)	follitropin beta	For Injection	Subcutaneous, Intramuscular	150IU	Single-Dose Vial	1997/09/29	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Carticel Sm Service	103661	001	351(a)	Autologous Cultured Chondrocytes	Injection	Implantation	12MIU/VL	Single-Dose Vial	1997/08/22	Vericel Corporation	Disc	Licensed		N/A
T.R.U.E. Test	103738	001	351(a)	Thin-Layer Rapid Use Epicutaneous Patch Test	Patch	Topical	36 MCG NICKEL/PATCH, 810 MCG WOOL ALCOHOL/PATCH, 486 MCG NEOMYCIN SULFATE/PATCH, 15.7 MCG CHROMIUM/PATCH, 510 MCG CAINE MIX/PATCH, 405 MCG FRAGRANCE MIX/PATCH, 972 MCG COLOPHONY/PATCH, 810 MCG PARABEN/PATCH, 648 MCG OF BALSAM OF PERU RESIN/PATCH, 18 MCG E	Pouch	1997/08/15	SmartPractice Denmark ApS	Rx	Licensed		N/A
Serostim	020604	003	351(a)	somatropin	For Injection	Subcutaneous	4MG	Multi-Dose Vial	1997/07/25	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
	101384	004	351(a)	Pollens - Grasses, Ryegrass, Perennial Lolium perenne	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1997/06/25	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked		N/A
	101382	004	351(a)	Pollens - Grasses, Orchard Grass Dactylis glomerata	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1997/05/29	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked		N/A
Benefix	103677	001	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	1000IU/ML	Single-Dose Vial	1997/02/11	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Benefix	103677	002	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	500IU/ML	Single-Dose Vial	1997/02/11	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Benefix	103677	003	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	250IU/ML	Single-Dose Vial	1997/02/11	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Infanrix	103647	001	351(a)	Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	Injection	Intramuscular	25LF/10LF/25UG/.5ML	Pre-Filled Syringe	1997/01/29	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Infanrix	103647	002	351(a)	Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	Injection	Intramuscular	25LF/10LF/25UG/.5ML	Single-Dose Vial	1997/01/29	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Cotazym	020580	001	351(a)	pancrelipase	Capsule, Delayed Release	Oral	8,000USP UNITS; 30,000USP UNITS; 30,000USP UNITS		1996/12/09	Organon USA Inc., a subsidiary of Merck & Co., Inc.	Disc	Voluntarily Revoked	N/A	N/A
Atgam	103676	001	351(a)	Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine)	Injection	Intravenous	50MG/ML	Ampule	1996/12/04	Pharmacia & Upjohn Company LLC	Rx	Licensed		N/A
Retavase	103786	001	351(a)	reteplase	For Injection	Intravenous	10UNITS	Single-Dose Vial	1996/10/30	Chiesi USA, Inc.	Rx	Licensed	N/A	N/A

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	-