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
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
Gintuit	125400	001	351(a)	Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen	Cellular Sheet	Topical	>0.000001UG/ML	Bag	2012/03/09	Organogenesis, Inc.	Disc	Licensed		N/A
Zomacton	019774	003	351(a)	somatropin	For Injection	Subcutaneous	10MG	Multi-Dose Vial	2012/03/07	Ferring Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Viokace	022542	001	351(a)	pancrelipase	Tablet	Oral	10,440USP UNITS; 39,150USP UNITS; 39,150USP UNITS		2012/03/01	Viokace, LLC	Rx	Licensed	N/A	N/A
Viokace	022542	002	351(a)	pancrelipase	Tablet	Oral	20,880USP UNITS; 78,300USP UNITS; 78,300USP UNITS		2012/03/01	Viokace, LLC	Rx	Licensed	N/A	N/A
Flumist, Flumist Quad	125020	002	351(a)	Influenza Vaccine Live, Intranasal	Suspension	Nasal	0.2ML	Pump Spray	2012/02/29	MedImmune, LLC	Disc	Licensed		N/A
Avonex	103628	003	351(a)	interferon beta-1a	Injection	Intramuscular	30MCG/0.5ML	Autoinjector	2012/02/27	Biogen Inc.	Rx	Licensed	N/A	N/A
Voraxaze	125327	001	351(a)	glucarpidase	For Injection	Intravenous	1,000UNITS	Single-Dose Vial	2012/01/17	BTG International Inc.	Rx	Licensed	N/A	N/A
Egrifta SV	022505	002	351(a)	tesamorelin	For Injection	Subcutaneous	2MG	Single-Dose Vial	2011/11/29	Theratechnologies Inc.	Rx	Licensed	N/A	N/A
Benefix	103677	005	351(a)	Coagulation Factor IX (Recombinant)	For Injection	Intravenous	3000IU/ML	Single-Dose Vial	2011/11/23	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A
Erwinaze	125359	001	351(a)	asparaginase Erwinia chrysanthemi	For Injection	Intravenous, Intramuscular	10,000INTERNATIONAL UNITS	Single-Dose Vial	2011/11/18	Jazz Pharmaceuticals, Inc.	Disc	Voluntarily Revoked	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	-