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
Renflexis	761054	001	351(k) Biosimilar	infliximab-abda	For Injection	Intravenous	100MG	Single-Dose Vial	2017/04/21	Samsung Bioepis Co., Ltd.	Rx	Licensed	infliximab	Remicade
Afstyla	125591	006	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	2500IU	Single-Dose Vial	2017/03/31	CSL Behring Lengnau AG	Rx	Licensed		N/A
Afstyla	125591	007	351(a)	Antihemophilic Factor (Recombinant), Single Chain	For Injection	Intravenous	1500IU	Single-Dose Vial	2017/03/31	CSL Behring Lengnau AG	Rx	Licensed		N/A
Orencia	125118	004	351(a)	abatacept	Injection	Subcutaneous	50MG/0.4ML	Pre-Filled Syringe	2017/03/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Orencia	125118	005	351(a)	abatacept	Injection	Subcutaneous	87.5MG/0.7ML	Pre-Filled Syringe	2017/03/30	Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Ocrevus	761053	001	351(a)	ocrelizumab	Injection	Intravenous	300MG/10ML (30MG/ML)	Single-Dose Vial	2017/03/28	Genentech, Inc.	Rx	Licensed	N/A	N/A
Dupixent	761055	001	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2017/03/28	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Dupixent	761055	002	351(a)	dupilumab	Injection	Subcutaneous	300MG/2ML	Pre-Filled Syringe	2017/03/28	Regeneron Pharmaceuticals, Inc.	Disc	Licensed	N/A	N/A
Bavencio	761049	001	351(a)	avelumab	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2017/03/23	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Adynovate	125566	007	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	3000IU	Single-Dose Vial	2017/03/13	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Flucelvax, Flucelvax Quadrivalent	125408	003	351(a)	Influenza Vaccine	Injection	Intramuscular	60UG/.5ML	Multi-Dose Vial	2017/03/03	Seqirus Inc.	Disc	Licensed	N/A	N/A
Rubber Panel T.R.U.E. Test	125579	001	351(a)	Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test	Patch	Topical	PATCH TEST 5 ALLERGEN AND ALLERGEN MIX PATCHES AND A NEGATIVE CONTROL.	Blister Pack	2017/03/03	SmartPractice Denmark ApS	Rx	Licensed		N/A
Odactra	125592	001	351(a)	House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract	Tablet	Sublingual	12 SQ-HDM/ML	Blister Pack	2017/03/01	ALK - Abello A/S	Rx	Licensed		N/A
Jetrea	125422	001	351(a)	ocriplasmin	Injection	Intravitreal	0.375MG/0.3ML (1.25MG/ML)	Single-Dose Vial	2017/02/22	ThromboGenics Inc.	Disc	Voluntarily Revoked	N/A	N/A
Siliq	761032	001	351(a)	brodalumab	Injection	Subcutaneous	210MG/1.5ML	Pre-Filled Syringe	2017/02/15	Bausch Health Ireland, Limited	Rx	Licensed	N/A	N/A
Herceptin	103792	002	351(a)	trastuzumab	For Injection	Intravenous	150MG	Single-Dose Vial	2017/02/10	Genentech, Inc.	Rx	Licensed	N/A	N/A
Gammaplex	125329	005	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5G/50ML	Single-Dose Vial	2017/02/06	Bio Products Laboratory Limited	Rx	Licensed		N/A
Gammaplex	125329	006	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	10G/100ML	Single-Dose Vial	2017/02/06	Bio Products Laboratory Limited	Rx	Licensed		N/A
Gammaplex	125329	007	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	20G/200ML	Single-Dose Vial	2017/02/06	Bio Products Laboratory Limited	Rx	Licensed		N/A
Eloctate	125487	008	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	5000IU	Single-Dose Vial	2017/01/27	Bioverativ Therapeutics, 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	-