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
Bivigam	125389	001	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5GM/50ML	Vial	2012/12/19	ADMA Biologics, Inc.	Rx	Licensed		N/A
Bivigam	125389	002	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10GM/100ML	Vial	2012/12/19	ADMA Biologics, Inc.	Rx	Licensed		N/A
Fluarix, Fluarix Quadrivalent	125127	002	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2012/12/14	GlaxoSmithKline Biologicals	Rx	Licensed		N/A
	125349	001	351(a)	raxibacumab	Injection	Intravenous	1,700MG/34ML (50MG/ML)	Single-Dose Vial	2012/12/14	Emergent Manufacturing Operations Baltimore LLC	Rx	Licensed	N/A	N/A
Evarrest	125392	001	351(a)	Fibrin Sealant Patch	Patch	Topical	50.3MG FIBRINOGEN&203.2IU THROMBIN/IN^2; 4x4 IN	Pouch	2012/12/05	Ethicon, Inc.	Disc	Licensed		N/A
Flucelvax, Flucelvax Quadrivalent	125408	001	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2012/11/20	Seqirus Inc.	Disc	Voluntarily Revoked		N/A
Jetrea	125422	002	351(a)	ocriplasmin	Injection	Intravitreal	0.5MG/0.2ML (2.5MG/ML)	Single-Dose Vial	2012/10/17	ThromboGenics Inc.	Disc	Voluntarily Revoked	N/A	N/A
Ducord	125407	001	351(a)	HPC, Cord Blood	Injection	Intravenous	GREATER THAN OR EQUAL TO 2.5 X 10E7 PER KG CELLS PER KILOGRAM	Bag	2012/10/04	Duke University School of Medicine	Rx	Licensed		N/A
Granix	125294	001	351(a)	tbo-filgrastim	Injection	Subcutaneous	300MCG/0.5ML	Pre-Filled Syringe	2012/08/29	UAB Teva Baltics	Rx	Licensed	N/A	N/A
Granix	125294	002	351(a)	tbo-filgrastim	Injection	Subcutaneous	480MCG/0.8ML	Pre-Filled Syringe	2012/08/29	UAB Teva Baltics	Rx	Licensed	N/A	N/A
Lucentis	125156	002	351(a)	ranibizumab	Injection	Intravitreal	6MG/ML (0.3MG/0.05ML)	Single-Dose Vial	2012/08/10	Genentech, Inc.	Disc*	Licensed	N/A	N/A
Zaltrap	125418	001	351(a)	Ziv-Aflibercept	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2012/08/03	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Zaltrap	125418	002	351(a)	Ziv-Aflibercept	Injection	Intravenous	200MG/8ML (25MG/ML)	Single-Dose Vial	2012/08/03	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Advate	125063	007	351(a)	Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method	For Injection	Intravenous	4,000IU	Single-Dose Vial	2012/07/12	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
MENHIBRIX	125363	001	351(a)	Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine	Injection	Intramuscular	0.5ML	Vial	2012/06/14	GlaxoSmithKline Biologicals	Disc	Voluntarily Revoked
Perjeta	125409	001	351(a)	pertuzumab	Injection	Intravenous	420MG/14ML	Single-Dose Vial	2012/06/08	Genentech, Inc.	Rx	Licensed	N/A	N/A
	125391	001	351(a)	HPC, Cord Blood	Injection	Intravenous	5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS	Bag	2012/05/24	Clinimmune Labs	Rx	Licensed		N/A
Pertzye	022175	001	351(a)	pancrelipase	Capsule, Delayed Release	Oral	8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS		2012/05/17	Digestive Care, Inc.	Rx	Licensed	N/A	N/A
Pertzye	022175	002	351(a)	pancrelipase	Capsule, Delayed Release	Oral	16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS		2012/05/17	Digestive Care, Inc.	Rx	Licensed	N/A	N/A
Elelyso	022458	001	351(a)	taliglucerase alfa	For Injection	Intravenous	200UNITS	Single-Dose Vial	2012/05/01	Pfizer Inc.	Rx	Licensed	N/A	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	-