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
Yesafili 761274 001 351(k) Interchangeable aflibercept-jbvf Injection Intravitreal 2MG/0.05ML Single-Dose Vial 2024/05/20 Biocon Biologics Inc. Rx Licensed aflibercept Eylea
Opuviz 761350 001 351(k) Interchangeable aflibercept-yszy Injection Intravitreal 2MG/0.05ML Single-Dose Vial 2024/05/20 Samsung Bioepis Co., Ltd. Rx Licensed aflibercept Eylea
Imdelltra 761344 001 351(a) tarlatamab-dlle Injection Intravenous 1MG Single-Dose Vial 2024/05/16 Amgen Inc. Rx Licensed
Imdelltra 761344 002 351(a) tarlatamab-dlle Injection Intravenous 10MG Single-Dose Vial 2024/05/16 Amgen Inc. Rx Licensed
Eticovo 761066 003 351(k) Biosimilar etanercept-ykro Injection Subcutaneous 50MG/ML Autoinjector 2024/05/03 Samsung Bioepis Co., Ltd. Disc Licensed etanercept Enbrel
Cyltezo 761058 005 351(k) Biosimilar adalimumab-adbm Injection Subcutaneous 40MG/0.4ML Pre-Filled Syringe 2024/04/30 Boehringer Ingelheim Pharmaceuticals, Inc. Rx Licensed adalimumab Humira
Cyltezo 761058 006 351(k) Biosimilar adalimumab-adbm Injection Subcutaneous 40MG/0.4ML Autoinjector 2024/04/30 Boehringer Ingelheim Pharmaceuticals, Inc. Rx Licensed adalimumab Humira
Hercessi 761346 001 351(k) Biosimilar trastuzumab-strf Injection Intravenous 150MG Single-Dose Vial 2024/04/25 Accord BioPharma Inc. Rx Licensed trastuzumab Herceptin
BEQVEZ 125786 001 351(a) fidanacogene elaparvovec-dzxt Suspension Intravenous 1x E13 VG/ML Single-Dose Vial 2024/04/25 Pfizer Inc. Rx Licensed
Anktiva 761336 001 351(a) nogapendekin alfa inbakicept-pmln Solution Intravesical 400MCG/0.4ML Single-Dose Vial 2024/04/22 Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. Rx Licensed
Selarsdi 761343 001 351(k) Biosimilar ustekinumab-aekn Injection Subcutaneous 45MG/0.5ML Pre-Filled Syringe 2024/04/16 Alvotech USA Inc. Rx Licensed ustekinumab Stelara
Selarsdi 761343 002 351(k) Biosimilar 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
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
Winrevair 761363 001 351(a) sotatercept-csrk For Injection Subcutaneous 45MG Single-Dose Vial 2024/03/26 Merck Sharp & Dohme LLC Rx Licensed
Winrevair 761363 002 351(a) sotatercept-csrk For Injection Subcutaneous 60MG Single-Dose Vial 2024/03/26 Merck Sharp & Dohme LLC Rx Licensed
Spevigo 761244 002 351(a) spesolimab-sbzo Injection Subcutaneous 150MG/ML Pre-Filled Syringe 2024/03/18 Boehringer Ingelheim Pharmaceuticals, Inc. Rx Licensed
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
Tevimbra 761232 001 351(a) tislelizumab-jsgr Injection Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial 2024/03/13 BeiGene USA, Inc. Rx Licensed
Jubbonti 761362 001 351(k) Interchangeable denosumab-bbdz Injection Subcutaneous 60MG/ML Pre-Filled Syringe 2024/03/05 Sandoz Inc. Rx Licensed denosumab Prolia
当前数据更新日期:2024年06月24日,更多信息请点击此处查询美国FDA药品数据库

数据库说明:

©2006-2024 DrugFuture->U.S. FDA Purple Book