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
N/A	102218	8	351(a)	Pollens - Grasses, Redtop Agrostis alba	Injection	Subcutaneous	100,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102219	1	351(a)	Pollens - Grasses, Ryegrass, Perennial Lolium perenne	Injection	Intradermal	10,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	1	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Intradermal	10,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	2	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Intradermal	10,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	3	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Subcutaneous	10,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	4	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	5	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Intradermal	100,000BAU/ML	Dropper Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	6	351(a)	Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum	Injection	Intradermal	100,000BAU/ML	Multi-Dose Vial	1974/03/12	Allermed Laboratories, Inc.	Rx	Licensed
N/A	102220	7	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	8	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
Koate, Koate-Dvi	101130	1	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	1,000IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed
Koate, Koate-Dvi	101130	2	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	250IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed
Koate, Koate-Dvi	101130	3	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	1974/01/24	Grifols Therapeutics LLC	Rx	Licensed
Novarel	017016	4	351(a)	chorionic gonadotropin	For Injection	Intramuscular	20,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Disc	Licensed
Novarel	017016	6	351(a)	chorionic gonadotropin	For Injection	Intramuscular	5,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Rx	Licensed
Novarel	017016	7	351(a)	chorionic gonadotropin	For Injection	Intramuscular	10,000UNITS	Multi-Dose Vial	1974/01/15	Ferring Pharmaceuticals Inc.	Disc	Licensed
Chorionic Gonadotropin	017067	1	351(a)	chorionic gonadotropin	For Injection	Intramuscular	5,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed
Chorionic Gonadotropin	017067	2	351(a)	chorionic gonadotropin	For Injection	Intramuscular	10,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Rx	Licensed
Chorionic Gonadotropin	017067	3	351(a)	chorionic gonadotropin	For Injection	Intramuscular	15,0000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed
Chorionic Gonadotropin	017067	4	351(a)	chorionic gonadotropin	For Injection	Intramuscular	20,000UNITS	Multi-Dose Vial	1973/03/05	Fresenius Kabi USA, LLC	Disc	Licensed

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	-