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
Sevenfact	125641	001	351(a)	coagulation factor VIIa (recombinant)-jncw	Injection	Intravenous	1MG	Single-Dose Vial	2020/04/01	Laboratoire Francais du Fractionnement et des Biotechnologies S.A.	Rx	Licensed
Sevenfact	125641	002	351(a)	coagulation factor VIIa (recombinant)-jncw	Injection	Intravenous	5MG	Single-Dose Vial	2020/04/01	Laboratoire Francais du Fractionnement et des Biotechnologies S.A.	Rx	Licensed
Pulmotech MAA	210089	001	351(a)	kit for the preparation of technetium Tc-99m albumin aggregated	For Injectable Suspension	Intravenous, Intraperitoneal	2MG	Multi-Dose Vial	2020/03/20	Cis Bio International	Rx	Licensed	N/A	N/A
Ontruzant	761100	002	351(k) Biosimilar	trastuzumab-dttb	For Injection	Intravenous	420MG	Multi-Dose Vial	2020/03/20	Samsung Bioepis Co., Ltd.	Rx	Licensed	trastuzumab	Herceptin
prolastin,prolastin-c,prolastin-c liquid	103174	004	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	4000MG/80ML	Single-Dose Vial	2020/03/05	Grifols Therapeutics LLC	Rx	Licensed		N/A
prolastin,prolastin-c,prolastin-c liquid	103174	005	351(a)	Alpha-1-Proteinase Inhibitor (Human)	Injection	Intravenous	500MG/10ML	Single-Dose Vial	2020/03/05	Grifols Therapeutics LLC	Rx	Licensed		N/A
Enbrel	103795	007	351(a)	etanercept	Injection	Subcutaneous	25MG/0.5ML	Single-Dose Vial	2020/03/05	Immunex Corporation	Rx	Licensed	N/A	N/A
Sarclisa	761113	001	351(a)	isatuximab-irfc	Injection	Intravenous	100MG/5ML (20MG/ML)	Single-Dose Vial	2020/03/02	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Sarclisa	761113	002	351(a)	isatuximab-irfc	Injection	Intravenous	500MG/25ML (20MG/ML)	Single-Dose Vial	2020/03/02	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Fluad,Fluad Quadrivalent	125510	002	351(a)	Influenza Vaccine, Adjuvanted	Injection	Intramuscular	60UG/.5ML	Pre-Filled Syringe	2020/02/21	Seqirus Inc.	Rx	Licensed
Vyepti	761119	001	351(a)	eptinezumab-jjmr	Injection	Intravenous	100MG/ML	Single-Dose Vial	2020/02/21	Lundbeck Seattle BioPharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Audenz	125692	001	351(a)	Influenza A (H5N1) Monovalent Vaccine, Adjuvanted	Injection	Intramuscular	7.5HA UG/.5ML	Multi-Dose Vial	2020/01/31	Seqirus Inc.	Disc	Licensed
Palforzia	125696	001	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	0.5MG	Capsule	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Palforzia	125696	002	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	1MG	Capsule	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Palforzia	125696	003	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	10MG	Capsule	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Palforzia	125696	004	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	20MG	Capsule	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Palforzia	125696	005	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	100MG	Capsule	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Palforzia	125696	006	351(a)	Peanut (Arachis hypogaea) Allergen Powder-dnfp	Powder	Oral	300MG	Sachet	2020/01/31	Greer Laboratories, Inc.	Rx	Licensed
Ajovy	761089	002	351(a)	fremanezumab-vfrm	Injection	Subcutaneous	225MG/1.5ML	Autoinjector	2020/01/27	Teva Branded Pharmaceutical Products R&D, Inc.	Rx	Licensed	N/A	N/A
Tepezza	761143	001	351(a)	teprotumumab-trbw	For Injection	Intravenous	500MG	Single-Dose Vial	2020/01/21	Horizon Therapeutics Ireland DAC	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	-