美国FDA生物制品紫皮书数据库
(U.S. FDA Purple Book: Database of Licensed Biological Products)
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
Rylaze 761179 001 351(a) asparaginase erwinia chrysanthemi (recombinant)-rywn Injection Intramuscular 10MG/0.5ML Single-Dose Vial 2021/06/30 Jazz Pharmaceuticals Ireland Limited Rx Licensed N/A N/A
StrataGraft 125730 001 351(a) Allogeneic Keratinocyte Cell Line (NIKS), Seeded on Rat Collagen (BD) Conditioned with Human Dermal Fibroblasts (Clonetics) Cell Sheets Topical 100CM SQUARED Pouch 2021/06/15 Stratatech Corporation Rx Licensed N/A N/A
Dupixent 761055 005 351(a) dupilumab Injection Subcutaneous 200MG/1.14ML Autoinjector 2021/06/14 Regeneron Pharmaceuticals, Inc. Rx Licensed N/A N/A
Prevnar 20 125731 001 351(a) 20-valent Pneumococcal Conjugate Vaccine Injection Intramuscular 0.5 ML Pre-Filled Syringe 2021/06/08 Wyeth Pharmaceuticals LLC Rx Licensed N/A N/A
Aduhelm 761178 001 351(a) aducanumab-avwa Injection Intravenous 170MG/1.7ML (100MG/ML) Single-Dose Vial 2021/06/07 Biogen Inc. Rx Licensed N/A N/A
Aduhelm 761178 002 351(a) aducanumab-avwa Injection Intravenous 300MG/3ML (100MG/ML) Single-Dose Vial 2021/06/07 Biogen Inc. Rx Licensed N/A N/A
Ryplazim 125659 001 351(a) plasminogen, human-tvmh For Injection Intravenous 68.8MG Single-Dose Vial 2021/06/04 ProMetic BioTherapeutics, Inc. Rx Licensed N/A N/A
Cosentyx 125504 004 351(a) secukinumab Injection Subcutaneous 75MG/0.5ML Pre-Filled Syringe 2021/05/28 Novartis Pharmaceuticals Corporation Rx Licensed N/A N/A
Rybrevant 761210 001 351(a) amivantamab-vmjw Injection Intravenous 350MG/7ML (50MG/ML) Single-Dose Vial 2021/05/21 Janssen Biotech, Inc. Rx Licensed N/A N/A
Pancreaze 022523 006 351(a) pancrelipase Capsule, Delayed Release Oral 37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS 2021/04/26 VIVUS, Inc. Rx Licensed N/A N/A
Skyrizi 761105 002 351(a) risankizumab-rzaa Injection Subcutaneous 150MG/ML Pre-Filled Syringe 2021/04/26 AbbVie Inc. Rx Licensed N/A N/A
Skyrizi 761105 003 351(a) risankizumab-rzaa Injection Subcutaneous 150MG/ML Autoinjector 2021/04/26 AbbVie Inc. Rx Licensed N/A N/A
Zynlonta 761196 001 351(a) loncastuximab tesirine-lpyl For Injection Intravenous 10MG Single-Dose Vial 2021/04/23 ADC Therapeutics SA Rx Licensed N/A N/A
Jemperli 761174 001 351(a) dostarlimab-gxly Injection Intravenous 500MG/10ML (50MG/ML) Single-Dose Vial 2021/04/22 GlaxoSmithKline LLC Rx Licensed N/A N/A
Flucelvax, Flucelvax Quadrivalent 125408 004 351(a) Influenza Vaccine Injection Intramuscular 60UG/.5ML Multi-Dose Vial 2021/03/26 Seqirus Inc. Rx Licensed N/A N/A
Flucelvax, Flucelvax Quadrivalent 125408 003 351(a) Influenza Vaccine Injection Intramuscular 60UG/.5ML Pre-Filled Syringe 2021/03/03 Seqirus Inc. Rx Licensed N/A N/A
Abecma 125736 001 351(a) idecabtagene vicleucel Injection Intravenous 150 TO 540 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS IN ONE OR MORE INFUSION Bag 2021/03/03 Celgene Corporation, a Bristol-Myers Squibb Company Rx Licensed N/A N/A
Evkeeza 761181 001 351(a) evinacumab-dgnb Injection Intravenous 345MG/2.3ML (150MG/ML) Single-Dose Vial 2021/02/11 Regeneron Pharmaceuticals, Inc. Rx Licensed N/A N/A
Evkeeza 761181 002 351(a) evinacumab-dgnb Injection Intravenous 1,200MG/8ML (150MG/ML) Single-Dose Vial 2021/02/11 Regeneron Pharmaceuticals, Inc. Rx Licensed N/A N/A
Breyanzi 125714 001 351(a) lisocabtagene maraleucel Injection Intravenous 4.6ML/VIAL Single-Dose Vial 2021/02/05 Juno Therapeutics, a Celgene Company Rx Licensed N/A N/A
当前数据更新日期:2021年07月25日,更多信息请点击此处查询美国FDA药品数据库

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