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	103397	007	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Percutaneous	5,000BAU/ML	Multi-Dose Vial	1958/09/15	Greer Laboratories, Inc.	Rx	Licensed
Baytet, Hypertet	101142	001	351(a)	Tetanus Immune Globulin (Human)	Injection	Intramuscular	250U	Pre-Filled Syringe	1957/10/17	Grifols Therapeutics LLC	Rx	Licensed
Buminate, Flexbumin	101452	001	351(a)	Albumin (Human)	Injection	Intravenous	20G/100ML	Bottle	1954/03/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Buminate, Flexbumin	101452	002	351(a)	Albumin (Human)	Injection	Intravenous	25G/100ML	Bottle	1954/03/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Buminate, Flexbumin	101452	003	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Bottle	1954/03/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Buminate, Flexbumin	101452	004	351(a)	Albumin (Human)	Injection	Intravenous	10G/50ML	Bottle	1954/03/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
Buminate, Flexbumin	101452	005	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/250ML	Bottle	1954/03/03	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed
N/A	101098	001	351(a)	Antivenin (Crotalidae) Polyvalent	For Injection	Intravenous	10ML	Vial	1954/02/08	Wyeth Pharmaceuticals LLC	Disc	Voluntarily Revoked
N/A	103052	001	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Percutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103052	002	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103052	003	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Percutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103052	004	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103053	001	351(a)	Pollens - Grasses, Fescue, Meadow Festuca elatior	Injection	Percutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103053	002	351(a)	Pollens - Grasses, Fescue, Meadow Festuca elatior	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103053	003	351(a)	Pollens - Grasses, Fescue, Meadow Festuca elatior	Injection	Percutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103053	004	351(a)	Pollens - Grasses, Fescue, Meadow Festuca elatior	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103054	001	351(a)	Pollens - Grasses, Orchard Grass Dactylis glomerata	Injection	Percutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103054	002	351(a)	Pollens - Grasses, Orchard Grass Dactylis glomerata	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103054	003	351(a)	Pollens - Grasses, Orchard Grass Dactylis glomerata	Injection	Percutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	Licensed
N/A	103054	004	351(a)	Pollens - Grasses, Orchard Grass Dactylis glomerata	Injection	Subcutaneous	100,000BAU/ML	Multi-Dose Vial	1950/09/29	ALK-Abello, Inc.	Rx	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License 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	-