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
Esperoct	125671	001	351(a)	Antihemophilic Factor (Recombinant), GlycoPEGylated-exei	For Injection	Intravenous	3000IU	Single-Dose Vial	2019/02/19	Novo Nordisk Inc.	Rx	Licensed		N/A
Esperoct	125671	002	351(a)	Antihemophilic Factor (Recombinant), GlycoPEGylated-exei	For Injection	Intravenous	1000IU	Single-Dose Vial	2019/02/19	Novo Nordisk Inc.	Rx	Licensed		N/A
Esperoct	125671	003	351(a)	Antihemophilic Factor (Recombinant), GlycoPEGylated-exei	For Injection	Intravenous	2000IU	Single-Dose Vial	2019/02/19	Novo Nordisk Inc.	Rx	Licensed		N/A
Esperoct	125671	004	351(a)	Antihemophilic Factor (Recombinant), GlycoPEGylated-exei	For Injection	Intravenous	500IU	Single-Dose Vial	2019/02/19	Novo Nordisk Inc.	Rx	Licensed		N/A
Esperoct	125671	005	351(a)	Antihemophilic Factor (Recombinant), GlycoPEGylated-exei	For Injection	Intravenous	1500IU	Single-Dose Vial	2019/02/19	Novo Nordisk Inc.	Rx	Licensed		N/A
Cuvitru	125596	005	351(a)	Immune Globulin Subcutaneous (Human), 20% Solution	Injection	Subcutaneous	10G/50ML	Single-Dose Vial	2019/02/07	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Cablivi	761112	001	351(a)	caplacizumab-yhdp	For injection	Intravenous, Subcutaneous	11MG	Single-Dose Vial	2019/02/06	Ablynx NV	Rx	Licensed	N/A	N/A
Jeuveau	761085	001	351(a)	prabotulinumtoxinA-xvfs	For Injection	Intramuscular	100UNITS	Single-Dose Vial	2019/02/01	Evolus Inc.	Rx	Licensed	N/A	N/A
Tremfya	761061	002	351(a)	guselkumab	Injection	Subcutaneous	100MG/ML	Autoinjector	2019/01/28	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Ontruzant	761100	001	351(k) Biosimilar	trastuzumab-dttb	For Injection	Intravenous	150MG	Single-Dose Vial	2019/01/18	Samsung Bioepis Co., Ltd.	Rx	Licensed	trastuzumab	Herceptin
Andexxa	125586	002	351(a)	Coagulation Factor Xa (Recombinant), Inactivated-zhzo	Injection	Intravenous	200MG	Single-Dose Vial	2018/12/31	AstraZeneca AB	Rx	Revoked		N/A
Vaxelis	125563	001	351(a)	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine	Injection	Intramuscular	0.5ML	Single-Dose Vial	2018/12/21	MSP Vaccine Company	Rx	Licensed		N/A
Ultomiris	761108	001	351(a)	ravulizumab-cwvz	Injection	Intravenous	300MG/30ML (10MG/ML)	Single-Dose Vial	2018/12/21	Alexion Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Elzonris	761116	001	351(a)	tagraxofusp-erzs	Injection	Intravenous	1,000MCG/1ML	Single-Dose Vial	2018/12/21	Stemline Therapeutics, Inc.	Rx	Licensed	N/A	N/A
Asparlas	761102	001	351(a)	calaspargase pegol-mknl	Injection	Intravenous	3,750UNITS/5ML (750UNITS/ML)	Single-Dose Vial	2018/12/20	Servier Pharmaceuticals LLC	Rx	Licensed	N/A	N/A
Herzuma	761091	001	351(k) Biosimilar	trastuzumab-pkrb	For Injection	Intravenous	420MG	Multi-Dose Vial	2018/12/14	CELLTRION, Inc.	Rx	Licensed	trastuzumab	Herceptin
Cutaquig	125668	001	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	1.65G/10 ML	Single-Dose Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Cutaquig	125668	002	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	3.3G/20 ML	Single-Dose Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Cutaquig	125668	003	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	1G/6ML	Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Cutaquig	125668	004	351(a)	Immune Globulin Subcutaneous (Human)-hipp	Solution	Subcutaneous	2G/12ML	Single-Dose Vial	2018/12/12	Octapharma Pharmazeutika Produktionsges.m.b.H.	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	-