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
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
Avonex	103628	001	351(a)	interferon beta-1a	For Injection	Intramuscular	30MCG	Single-Dose Vial	1996/05/17	Biogen Inc.	Disc	Licensed	N/A	N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	001	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intramuscular	5000IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	002	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intravenous	5000IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	003	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intramuscular	1500IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	004	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intravenous	1500IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	005	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intramuscular	600IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized	103649	006	351(a)	Rho(D) Immune Globulin Intravenous (Human)	For Injection	Intravenous	600IU	Vial	1996/04/02	Kamada Ltd.	Disc	Licensed		N/A
Vaqta	103606	001	351(a)	Hepatitis A Vaccine Inactivated	Injection	Intramuscular	50U/ML	Pre-Filled Syringe	1996/03/29	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Vaqta	103606	002	351(a)	Hepatitis A Vaccine Inactivated	Injection	Intramuscular	25U/.5ML	Pre-Filled Syringe	1996/03/29	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Vaqta	103606	003	351(a)	Hepatitis A Vaccine Inactivated	Injection	Intramuscular	50U/ML	Single-Dose Vial	1996/03/29	Merck Sharp & Dohme LLC	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	-