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
Kalbitor	125277	001	351(a)	ecallantide	Injection	Subcutaneous	10MG/ML	Single-Dose Vial	2009/12/01	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed	N/A	N/A
Agriflu	125297	001	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	.05ML	Syringe	2009/11/27	Seqirus Inc.	Disc	Licensed		N/A
Flulaval, Flulaval Quadrivalent	125163	002	351(a)	Influenza Vaccine	Injection	Intramuscular	15UG/.5ML	Multi-Dose Vial	2009/11/10	ID Biomedical Corporation of Quebec	Disc	Licensed		N/A
Arzerra	125326	001	351(a)	ofatumumab	Injection	Intravenous	100MG/5ML	Single-Dose Vial	2009/10/26	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Cervarix	125259	001	351(a)	Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant	Injection	Intramuscular	0.5ML	Pre-Filled Syringe	2009/10/16	GlaxoSmithKline Biologicals	Disc	Licensed		N/A
Berinert	125287	001	351(a)	C1 Esterase Inhibitor (Human)	For Injection	Intravenous	500U	Single-Dose Vial	2009/10/09	CSL Behring GmbH	Rx	Licensed		N/A
Privigen	125201	004	351(a)	Immune Globulin Intravenous (Human), 10% Liquid	Injection	Intravenous	2.5G	Single-Dose Vial	2009/10/02	CSL Behring AG	Rx	Licensed		N/A
Stelara	125261	001	351(a)	ustekinumab	Injection	Subcutaneous	45MG/0.5ML	Single-Dose Vial	2009/09/25	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Stelara	125261	002	351(a)	ustekinumab	Injection	Subcutaneous	90MG/ML	Single-Dose Vial	2009/09/25	Janssen Biotech, Inc.	Disc	Licensed	N/A	N/A
Evithrom	125247	004	351(a)	Thrombin, Topical (Human)	For Injection	Topical	1600-2400IU/ML	Single-dose vial	2009/09/17	Omrix Biopharmaceuticals Ltd	Rx	Licensed		N/A
Gammaplex	125329	001	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10G/200ML	Single-Dose Vial	2009/09/17	Bio Products Laboratory Limited	Disc	Licensed		N/A
Gammaplex	125329	002	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	2.5G/50ML	Single-Dose Vial	2009/09/17	Bio Products Laboratory Limited	Disc	Licensed		N/A
Gammaplex	125329	003	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5G/100ML	Single-Dose Vial	2009/09/17	Bio Products Laboratory Limited	Disc	Licensed		N/A
Zenpep	022210	001	351(a)	pancrelipase	Capsule, Delayed Release	Oral	5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS		2009/08/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Zenpep	022210	002	351(a)	pancrelipase	Capsule, Delayed Release	Oral	10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS		2009/08/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Zenpep	022210	003	351(a)	pancrelipase	Capsule, Delayed Release	Oral	15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS		2009/08/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Zenpep	022210	004	351(a)	pancrelipase	Capsule, Delayed Release	Oral	20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS		2009/08/27	Zenpep, LLC	Rx	Licensed	N/A	N/A
Hiberix	125347	001	351(a)	Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)	For Injection	Intramuscular	10UG/25UG	Single-Dose Vial	2009/08/19	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
Extavia	125290	001	351(a)	interferon beta-1b	For Injection	Subcutaneous	0.3MG	Single-Dose Vial	2009/08/14	Novartis Pharmaceuticals Corporation	Disc	Voluntarily Revoked	N/A	N/A
Helixate Fs, Kogenate, Kogenate Fs	103332	005	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	3000IU	Single-Dose Vial	2009/07/31	Bayer HealthCare LLC	Disc	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	-