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
	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
ProstaScint	103608	001	351(a)	capromab pendetide	Injection	Intravenous	0.5MG/1ML	Single-Dose Vial	1996/10/28	Aytu BioScience, Inc.	Disc	Licensed	N/A	N/A
Genotropin	020280	007	351(a)	somatropin	For Injection	Subcutaneous	12MG	Multi-Dose Cartridge	1996/10/23	Pharmacia & Upjohn Company LLC	Rx	Licensed	N/A	N/A
Saizen	019764	001	351(a)	somatropin	For Injection	Subcutaneous	6MG	Single-Dose Vial	1996/10/08	EMD Serono, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Saizen	019764	002	351(a)	somatropin	For Injection	Subcutaneous	5MG	Single-Dose Vial	1996/10/08	EMD Serono, Inc.	Disc	Voluntarily Revoked	N/A	N/A
COMVAX	103623	001	351(a)	Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine	Injection	Intramuscular	7.5UG PRP/125UG OMPC/5UG HBsAg	Vial	1996/10/02	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
Serostim	020604	001	351(a)	somatropin	For Injection	Subcutaneous	6MG	Single-Dose Vial	1996/08/23	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Serostim	020604	002	351(a)	somatropin	For Injection	Subcutaneous	5MG	Single-Dose Vial	1996/08/23	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Humalog	020563	001	351(a)	insulin lispro	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	1996/06/14	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Humalog	020563	006	351(a)	insulin lispro	Injection	Intravenous, Subcutaneous	300UNITS/3ML (100UNITS/ML)	Multi-Dose Vial	1996/06/14	Eli Lilly and Company	Rx	Licensed	N/A	N/A
Acthrel	020162	001	351(a)	corticorelin ovine triflutate	For Injection	Intravenous	100MCG	Single-Dose Vial	1996/05/23	Ferring Pharmaceuticals Inc.	Disc	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	-