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
Chorionic Gonadotropin	017067	001	351(a)	chorionic gonadotropin	For Injection	Intramuscular	5,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed	N/A	N/A
Chorionic Gonadotropin	017067	002	351(a)	chorionic gonadotropin	For Injection	Intramuscular	10,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	N/A	N/A
Chorionic Gonadotropin	017067	003	351(a)	chorionic gonadotropin	For Injection	Intramuscular	15,0000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed	N/A	N/A
Chorionic Gonadotropin	017067	004	351(a)	chorionic gonadotropin	For Injection	Intramuscular	20,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed	N/A	N/A
	103810	001	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1971/12/16	ALK-Abello, Inc.	Rx	Licensed		N/A
	103810	002	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1971/12/16	ALK-Abello, Inc.	Rx	Licensed		N/A
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose	101141	001	351(a)	Rho(D) Immune Globulin (Human)	Injection	Intramuscular	1500IU	Pre-Filled Syringe	1971/06/11	Grifols Therapeutics LLC	Rx	Licensed		N/A
Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose	101141	002	351(a)	Rho(D) Immune Globulin (Human)	Injection	Intramuscular	250IU	Pre-Filled Syringe	1971/06/11	Grifols Therapeutics LLC	Rx	Licensed		N/A
M-M-R Ii	101069	001	351(a)	Measles, Mumps and Rubella Virus Vaccine Live	For Injection	Subcutaneous	0.5ML	Single-Dose Vial	1971/04/22	Merck Sharp & Dohme LLC	Rx	Licensed		N/A
Proplex-T; Bebulin	103112	001	351(a)	Factor IX Complex	For Injection	Intravenous	200-1200U/20ML	Vial	1970/08/21	Baxalta US Inc.	Rx	Voluntarily Revoked
Tdvax	101322	001	351(a)	Tetanus and Diphtheria Toxoids Adsorbed	Injection	Intramuscular	0.5ML	Single-Dose Vial	1970/07/27	MassBiologics	Disc	Licensed		N/A
MERUVAX II	101075	001	351(a)	Rubella Virus Vaccine Live	For Injection	Subcutaneous	NLT1000U/.5ML	Vial	1969/06/09	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
MumpsVax	101072	001	351(a)	Mumps Virus Vaccine Live	For Injection	Subcutaneous	0.5ML	Vial	1967/12/28	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
	101099	001	351(a)	Antivenin (Micrurus fulvius)	For Injection	Intravenous	10ML	Vial	1967/08/28	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Santyl	101995	001	351(a)	collagenase	Ointment	Topical	250UNITS/GRAM	Tube	1965/06/04	Smith & Nephew, Inc.	Rx	Licensed	N/A	N/A
Elase-chloromycetin	050294	001	351(a)	fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol	Ointment	Topical	10MG/GM; 666UNITS/GM; 1UNIT/GM	Tube	1964/04/01	Parke-Davis, a Division of Pfizer Inc.	Disc	Voluntarily Revoked	N/A	N/A
ATTENUVAX	101068	001	351(a)	Measles Virus Vaccine Live	For Injection	Subcutaneous	NLT1000U/.5ML	Vial	1963/03/21	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked
Plasmanate	101140	001	351(a)	Plasma Protein Fraction (Human)	Injection	Intravenous	25G/500ML	Single-Dose Vial	1958/10/02	Grifols Therapeutics LLC	Disc	Licensed		N/A
Plasmanate	101140	002	351(a)	Plasma Protein Fraction (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	1958/10/02	Grifols Therapeutics LLC	Disc	Licensed		N/A
Plasmanate	101140	003	351(a)	Plasma Protein Fraction (Human)	Injection	Intravenous	12.5G/250ML	Single-Dose Vial	1958/10/02	Grifols Therapeutics LLC	Rx	Licensed		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	-