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
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
hudquzco rubber panel,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
Eloctate	125487	009	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	6000IU	Single-Dose Vial	2017/01/27	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Eloctate	125487	010	351(a)	Antihemophilic Factor (Recombinant), Fc Fusion protein	For Injection	Intravenous	4000IU	Single-Dose Vial	2017/01/27	Bioverativ Therapeutics, Inc.	Rx	Licensed		N/A
Ilaris	125319	002	351(a)	canakinumab	Injection	Subcutaneous	150MG/ML	Single-Dose Vial	2016/12/22	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Maci	125603	001	351(a)	autologous cultured chondrocytes on porcine collagen membrane	Cell Sheets	Implantation	500,000 CM2 CM2	Pouch	2016/12/13	Vericel Corporation	Rx	Licensed		N/A
Xultophy 100/3.6	208583	001	351(a)	insulin degludec and liraglutide	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML); 10.8MG/3ML (3.6MG/ML)	Autoinjector	2016/11/21	Novo Nordisk Inc.	Rx	Licensed	N/A	N/A
Soliqua 100/33	208673	001	351(a)	insulin glargine and lixisenatide	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML); 99MCG/3ML (33MCG/ML)	Autoinjector	2016/11/21	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Adynovate	125566	005	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	1500IU	Single-Dose Vial	2016/10/25	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Adynovate	125566	006	351(a)	Antihemophilic Factor (Recombinant), PEGylated	For Injection	Intravenous	750IU	Single-Dose Vial	2016/10/25	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Zinplava	761046	001	351(a)	bezlotoxumab	Injection	Intravenous	1,000MG/40ML (25MG/ML)	Single-Dose Vial	2016/10/21	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Lartruvo	761038	001	351(a)	olaratumab	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2016/10/19	Eli Lilly and Company	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	-