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
Eylea	125387	001	351(a)	aflibercept	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2011/11/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Hemacord	125397	001	351(a)	Hematopoietic Progenitor Cells, Cord (HPC-C)	Injection	Intravenous	5 X 10E8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 X 10E6 VIABLE CD34+ CELLS U	Bag	2011/11/10	New York Blood Center, Inc.	Rx	Licensed		N/A
Pegasys	103964	003	351(a)	peginterferon alfa-2a	Injection	Subcutaneous	180MCG/0.5ML	Autoinjector	2011/09/29	pharmaand GmbH	Disc	Licensed	N/A	N/A
Pegasys	103964	004	351(a)	peginterferon alfa-2a	Injection	Subcutaneous	135MCG/0.5ML	Autoinjector	2011/09/29	pharmaand GmbH	Disc	Licensed	N/A	N/A
Adcetris	125388	001	351(a)	brentuximab vedotin	For Injection	Intravenous	50MG	Single-Dose Vial	2011/08/19	Seagen Inc.	Rx	Licensed	N/A	N/A
Anascorp	125335	001	351(a)	Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection	For Injection	Intravenous	>/=150 LD50 NEUTRALIZING UNITS	Single-Dose Vial	2011/08/03	Rare Disease Therapeutics, Inc. (RDT)	Rx	Licensed		N/A
Orencia	125118	002	351(a)	abatacept	Injection	Subcutaneous	125MG/ML	Pre-Filled Syringe	2011/07/29	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Spherusol	125354	001	351(a)	Coccidioides immitis Spherule-Derived Skin Test Antigen	Injection	Intradermal	1.0ML	Multi-Dose Vial	2011/07/29	Nielsen Bioscience, Inc	Rx	Licensed		N/A
Zenpep	022210	006	351(a)	pancrelipase	Capsule, Delayed Release	Oral	25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS		2011/07/13	Zenpep, LLC	Rx	Licensed	N/A	N/A
Laviv	125348	001	351(a)	Azficel-T	Injection	Intradermal	18MU CELL/ML	Vial	2011/06/21	Fibrocell Technologies, Inc.	Disc	Licensed		N/A
Zenpep	022210	005	351(a)	pancrelipase	Capsule, Delayed Release	Oral	3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS		2011/06/15	Zenpep, LLC	Rx	Licensed	N/A	N/A
Nulojix	125288	001	351(a)	belatacept	For Injection	Intravenous	250MG	Single-Dose Vial	2011/06/15	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Creon	020725	004	351(a)	pancrelipase	Capsule, Delayed Release	Oral	3,000USP UNITS; 9,500USP UNITS; 15,000USP UNITS		2011/06/10	AbbVie Inc.	Rx	Licensed	N/A	N/A
Kedbumin	125384	001	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	2011/06/03	Kedrion Biopharma Inc.	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	004	351(a)	Influenza Virus Vaccine	Injection	Intradermal	27UG/0.1	Syringe	2011/05/09	Sanofi Pasteur Inc.	Disc	Licensed		N/A
Arzerra	125326	002	351(a)	ofatumumab	Injection	Intravenous	1,000MG/50ML	Single-Dose Vial	2011/04/01	Novartis Pharmaceuticals Corporation	Disc	Licensed	N/A	N/A
Sylatron	103949	002	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	200MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Sylatron	103949	003	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	300MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Sylatron	103949	004	351(a)	peginterferon alfa-2b	For Injection	Subcutaneous	600MCG	Single-Dose Vial	2011/03/29	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Yervoy	125377	001	351(a)	ipilimumab	Injection	Intravenous	50MG/10ML (5MG/ML)	Single-Dose Vial	2011/03/25	Bristol-Myers Squibb Company	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	-