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
ALTUVIIIO 125771 1 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 250IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 2 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 500IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 3 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 750IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 4 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 1000IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 5 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 2000IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 6 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 3000IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
ALTUVIIIO 125771 7 351(a) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl For Injection Intravenous 4000IU Single-Dose Vial 2023/02/22 Bioverativ Therapeutics, Inc. Rx Licensed
Lamzede 761278 1 351(a) velmanase alfa-tycv For Injection Intravenous 10MG Single-Dose Vial 2023/02/16 Chiesi Farmaceutici S.p.A. Rx Licensed
Takhzyro 761090 3 351(a) lanadelumab-flyo Injection Subcutaneous 150MG/1ML (150MG/ML) Pre-Filled Syringe 2023/02/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
Tezspire 761224 3 351(a) tezepelumab-ekko Injection Subcutaneous 210MG/1.91ML (110MG/ML) Autoinjector 2023/02/01 AstraZeneca AB Rx Licensed
Leqembi 761269 1 351(a) lecanemab-irmb Injection Intravenous 200MG/2ML (100MG/ML) Single-Dose Vial 2023/01/06 Eisai, Incorporated Rx Licensed
Leqembi 761269 2 351(a) lecanemab-irmb Injection Intravenous 500MG/5ML (100MG/ML) Single-Dose Vial 2023/01/06 Eisai, Incorporated Rx Licensed
Briumvi 761238 1 351(a) ublituximab-xiiy Injection Intravenous 150MG/6ML (25MG/ML) Single-Dose Vial 2022/12/28 TG Therapeutics, Inc. Rx Licensed
Nexobrid 761192 1 351(a) anacaulase-bcdb For Topical Gel Topical 8.8% (1.94GM) Single-Use Jar 2022/12/28 MediWound, Ltd. Rx Licensed
Nexobrid 761192 2 351(a) anacaulase-bcdb For Topical Gel Topical 8.8% (4.85GM) Single-Use Jar 2022/12/28 MediWound, Ltd. Rx Licensed
Lunsumio 761263 1 351(a) mosunetuzumab-axgb Injection Intravenous 1MG/ML Single-Dose Vial 2022/12/22 Genentech, Inc. Rx Licensed
Lunsumio 761263 2 351(a) mosunetuzumab-axgb Injection Intravenous 30MG/30ML (1MG/ML) Single-Dose Vial 2022/12/22 Genentech, Inc. Rx Licensed
Adstiladrin 125700 1 351(a) nadofaragene firadenovec-vncg For Suspension Intravesical 3x10^11 viral particles (vp)/mL Single-Dose Vial 2022/12/16 Ferring Pharmaceuticals A/S Rx Licensed
Idacio 761255 1 351(k) Biosimilar adalimumab-aacf Injection Subcutaneous 40MG/0.8ML Autoinjector 2022/12/13 Fresenius Kabi USA, LLC Rx Licensed adalimumab Humira
Idacio 761255 2 351(k) Biosimilar adalimumab-aacf Injection Subcutaneous 40MG/0.8ML Pre-Filled Syringe 2022/12/13 Fresenius Kabi USA, LLC Rx Licensed adalimumab Humira
当前数据更新日期:2023年03月23日,更多信息请点击此处查询美国FDA药品数据库

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