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
Abrilada	761118	004	351(k) Interchangeable	adalimumab-afzb	Injection	Subcutaneous	10MG/0.2ML	Pre-Filled Syringe	2019/11/15	Pfizer Inc.	Disc	Licensed	adalimumab	Humira
Abrilada	761118	005	351(k) Interchangeable	adalimumab-afzb	Injection	Subcutaneous	40MG/0.8ML	Single-Dose Vial	2019/11/15	Pfizer Inc.	Rx	Licensed	adalimumab	Humira
Adakveo	761128	001	351(a)	crizanlizumab-tmca	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2019/11/15	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Reblozyl	761136	001	351(a)	luspatercept-aamt	For Injection	Subcutaneous	25MG/VIAL	Single-Dose Vial	2019/11/08	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Reblozyl	761136	002	351(a)	luspatercept-aamt	For Injection	Subcutaneous	75MG/VIAL	Single-Dose Vial	2019/11/08	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Bayrab,Hyperrab	101144	003	351(a)	Rabies Immune Globulin (Human)	Injection	Intramuscular	900 IU/ 3ML	Single-Dose Vial	2019/11/06	Grifols Therapeutics LLC	Rx	Licensed		N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	009	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	240UG/.7ML	Pre-Filled Syringe	2019/11/04	Sanofi Pasteur Inc.	Rx	Licensed	N/A
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent	103914	010	351(a)	Influenza Virus Vaccine	Injection	Intramuscular	45UG/.5ML	Multi-Dose Vial	2019/11/04	Sanofi Pasteur Inc.	Rx	Licensed	N/A
Ziextenzo	761045	001	351(k) Biosimilar	pegfilgrastim-bmez	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2019/11/04	Sandoz Inc.	Rx	Licensed	pegfilgrastim	Neulasta
Kanjinti	761073	002	351(k) Biosimilar	trastuzumab-anns	For Injection	Intravenous	150MG	Single-Dose Vial	2019/10/25	Amgen Inc.	Rx	Licensed	trastuzumab	Herceptin
Beovu	761125	001	351(a)	brolucizumab-dbll	Injection	Intravitreal	6MG/0.05ML	Single-Dose Vial	2019/10/07	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Fasenra	761070	002	351(a)	benralizumab	Injection	Subcutaneous	30MG/ML	Autoinjector	2019/10/03	AstraZeneca AB	Rx	Licensed	N/A	N/A
Jynneos	125678	001	351(a)	Smallpox and Mpox Vaccine, Live, Non-replicating	Injection	Subcutaneous	0.5-3.95 X 10E8 INF. U/.5ML	Single-Dose Vial	2019/09/24	Bavarian Nordic A/S	Rx	Licensed		N/A
Hadlima	761059	001	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.8ML	Autoinjector	2019/07/23	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Hadlima	761059	002	351(k) Interchangeable	adalimumab-bwwd	Injection	Subcutaneous	40MG/0.8ML	Pre-Filled Syringe	2019/07/23	Samsung Bioepis Co., Ltd.	Rx	Licensed	adalimumab	Humira
Ruxience	761103	001	351(k) Biosimilar	rituximab-pvvr	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2019/07/23	Pfizer Ireland Pharmaceuticals	Rx	Licensed	rituximab	Rituxan
Ruxience	761103	002	351(k) Biosimilar	rituximab-pvvr	Injection	Intravenous	500MG/50ML (10MG/ML)	Single-Dose Vial	2019/07/23	Pfizer Ireland Pharmaceuticals	Rx	Licensed	rituximab	Rituxan
Nplate	125268	003	351(a)	romiplostim	For Injection	Subcutaneous	125MCG	Single-Dose Vial	2019/07/22	Amgen Inc.	Rx	Licensed	N/A	N/A
Xembify	125683	001	351(a)	immune globulin subcutaneous, human-klhw	Injection	Subcutaneous	4GM MG/ML	Single-Dose Vial	2019/07/03	Grifols Therapeutics LLC	Rx	Licensed		N/A
Xembify	125683	002	351(a)	immune globulin subcutaneous, human-klhw	Injection	Subcutaneous	10GM MG/ML	Single-Dose Vial	2019/07/03	Grifols Therapeutics LLC	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	-