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
Selarsdi	761343	002	351(k) Interchangeable	ustekinumab-aekn	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/04/16	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Fasenra	761070	003	351(a)	benralizumab	Injection	Subcutaneous	10MG/0.5ML	Pre-Filled Syringe	2024/04/05	AstraZeneca AB	Rx	Licensed	N/A	N/A
Abecma	125736	002	351(a)	idecabtagene vicleucel	Suspension	Intravenous	300 to 510 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS	Bag	2024/04/04	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Winrevair	761363	001	351(a)	sotatercept-csrk	For Injection	Subcutaneous	45MG	Single-Dose Vial	2024/03/26	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Winrevair	761363	002	351(a)	sotatercept-csrk	For Injection	Subcutaneous	60MG	Single-Dose Vial	2024/03/26	Merck Sharp & Dohme LLC	Rx	Licensed	N/A	N/A
Lenmeldy	125758	001	351(a)	atidarsagene autotemcel	Suspension	Intravenous	2 x 10^6 to 11.8 x 10^6CELL/ML	Bag	2024/03/18	Orchard Therapeutics (Europe) Ltd.	Rx	Licensed	N/A	N/A
Spevigo	761244	002	351(a)	spesolimab-sbzo	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2024/03/18	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Tevimbra	761232	001	351(a)	tislelizumab-jsgr	Injection	Intravenous	100MG/10ML (10MG/ML)	Single-Dose Vial	2024/03/13	BeiGene USA, Inc.	Rx	Licensed	N/A	N/A
Tyenne	761275	001	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	80MG/4ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Tyenne	761275	002	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	200MG/10ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Tyenne	761275	003	351(k) Biosimilar	tocilizumab-aazg	Injection	Intravenous	400MG/20ML (20MG/ML)	Single-Dose Vial	2024/03/05	Fresenius Kabi USA, LLC	Rx	Licensed	tocilizumab	Actemra
Jubbonti	761362	001	351(k) Interchangeable	denosumab-bbdz	Injection	Subcutaneous	60MG/ML	Pre-Filled Syringe	2024/03/05	Sandoz Inc.	Disc	Licensed	denosumab	Prolia
Wyost	761362	002	351(k) Interchangeable	denosumab-bbdz	Injection	Subcutaneous	120MG/1.7ML (70MG/ML)	Single-Dose Vial	2024/03/05	Sandoz Inc.	Disc	Licensed	denosumab	Xgeva
Flublok	125285	003	351(a)	Influenza Vaccine	Injection	Intramuscular	135UG/.5ML	Pre-Filled Syringe	2024/03/04	Protein Sciences Corporation	Rx	Licensed		N/A
Flucelvax, Flucelvax Quadrivalent	125408	004	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Multi-Dose Vial	2024/03/04	Seqirus Inc.	Rx	Licensed	N/A	N/A
Flucelvax, Flucelvax Quadrivalent	125408	005	351(a)	Influenza Vaccine	Injection	Intramuscular	45UG/.5ML	Pre-Filled Syringe	2024/03/04	Seqirus Inc.	Rx	Licensed	N/A	N/A
Letybo	761225	001	351(a)	letibotulinumtoxinA-wlbg	For Injection	Intramuscular	50UNITS	Single-Dose Vial	2024/02/29	Hugel, Inc.	Rx	Licensed	N/A	N/A
Letybo	761225	002	351(a)	letibotulinumtoxinA-wlbg	For Injection	Intramuscular	100UNITS	Single-Dose Vial	2024/02/29	Hugel, Inc.	Rx	Licensed	N/A	N/A
Simlandi	761299	001	351(k) Interchangeable	adalimumab-ryvk	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2024/02/23	Alvotech USA Inc.	Rx	Licensed	adalimumab	Humira
AMTAGVI	125773	001	351(a)	Lifileucel	Suspension	Intravenous	7.5x10^9 to 72x10^9Cells	Bag	2024/02/16	Iovance Biotherapeutics, Inc.	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	-