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
Flulaval, Flulaval Quadrivalent	125163	005	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2013/09/27	ID Biomedical Corporation of Quebec	Disc	Licensed		N/A
Kedbumin	125384	002	351(a)	Albumin (Human)	Injection	Intravenous	25G/100ML	Single-Dose Vial	2013/09/05	Kedrion Biopharma Inc.	Rx	Licensed		N/A
Flulaval, Flulaval Quadrivalent	125163	003	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Multi-Dose Vial	2013/08/15	ID Biomedical Corporation of Quebec	Disc	Licensed		N/A
Simponi Aria	125433	001	351(a)	golimumab	Injection	Intravenous	50MG/4ML (12.5MG/ML)	Single-Dose Vial	2013/07/18	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Rixubis	125446	001	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	500IU	Single-Dose Vial	2013/06/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Rixubis	125446	002	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	1000IU	Single-Dose Vial	2013/06/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Rixubis	125446	003	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	2013/06/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Rixubis	125446	004	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	3000IU	Single-Dose Vial	2013/06/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Rixubis	125446	005	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	2000IU	Single-Dose Vial	2013/06/26	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Cordcyte	125432	001	351(a)	HPC, Cord Blood	Injection	Intravenous	TOTAL NUCLEATED CELLS CELL/ML	Bag	2013/06/13	LifeSouth Community Blood Centers, Inc.	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	005	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2013/06/07	Sanofi Pasteur Inc.	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	006	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	60UG/.5ML	Single-Dose Vial	2013/06/07	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	007	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	60UG/.5ML	Multi-Dose Vial	2013/06/07	Sanofi Pasteur Inc.	Rx	Licensed		N/A
Allocord	125413	001	351(a)	HPC, Cord Blood	Injection	Intravenous	TOTAL NUCLEATED CELLS CELL/ML	Bag	2013/05/30	SSM Cardinal Glennon Children's Medical Center	Rx	Licensed		N/A
Evarrest	125392	002	351(a)	Fibrin Sealant Patch	Patch	Topical	55.5MG FIBRINOGEN&241.9IU THROMBIN/IN^2; 4x4 IN	Pouch	2013/05/16	Ethicon, Inc.	Disc	Licensed		N/A
Simponi	125289	003	351(a)	golimumab	Injection	Subcutaneous	100MG/ML	Autoinjector	2013/05/15	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Simponi	125289	004	351(a)	golimumab	Injection	Subcutaneous	100MG/ML	Pre-Filled Syringe	2013/05/15	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Kcentra	125421	001	351(a)	Prothrombin Complex Concentrate (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	2013/04/29	CSL Behring GmbH	Rx	Licensed		N/A
Humira	125057	004	351(a)	adalimumab	Injection	Subcutaneous	40MG/0.8ML	Single-Dose Vial	2013/04/24	AbbVie Inc.	Disc	Licensed	N/A	N/A
Bat	125462	001	351(a)	Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)	Solution	Intravenous	>4500U	Single-Dose Vial	2013/03/22	Emergent BioSolutions Canada Inc.	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	-