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
	102220	007	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Subcutaneous	100,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed		N/A
	102220	008	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed		N/A
	103473	001	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed		N/A
	103473	002	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed		N/A
Koate, Koate-Dvi	101130	001	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	1,000IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed		N/A
Koate, Koate-Dvi	101130	002	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	250IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed		N/A
Koate, Koate-Dvi	101130	003	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed		N/A
Novarel	017016	004	351(a)	chorionic gonadotropin	For Injection	Intramuscular	20,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Novarel	017016	006	351(a)	chorionic gonadotropin	For Injection	Intramuscular	5,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Novarel	017016	007	351(a)	chorionic gonadotropin	For Injection	Intramuscular	10,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
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

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	-