美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=BORTEZOMIB"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
BORTEZOMIB 215011 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2022/07/26 2022/07/26 JIANGSU HANSOH PHARM Prescription
BORTEZOMIB 215441 001 NDA BORTEZOMIB SOLUTION;INTRAVENOUS 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2022/07/26 2022/07/26 ACCORD HLTHCARE Discontinued
BORTEZOMIB 215441 002 NDA BORTEZOMIB SOLUTION;INTRAVENOUS 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2022/07/26 2022/07/26 ACCORD HLTHCARE Discontinued
BORTEZOMIB 215331 001 NDA BORTEZOMIB SOLUTION;INTRAVENOUS 3.5MG/3.5ML (1MG/ML) Yes No 2022/07/27 2022/07/27 MAIA PHARMS INC Discontinued
BORTEZOMIB 215331 002 NDA BORTEZOMIB SOLUTION;INTRAVENOUS 3.5MG/1.4ML (2.5MG/ML) Yes No 2022/07/27 2022/07/27 MAIA PHARMS INC Discontinued
BORTEZOMIB 211898 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2022/10/11 2022/10/11 RELIANCE LIFE SCI Prescription
BORTEZOMIB 205160 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2022/10/31 2022/10/31 PHARMOBEDIENT Discontinued
BORTEZOMIB 216912 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2023/09/26 2023/09/26 SCINOPHARM TAIWAN Discontinued
BORTEZOMIB 212204 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2024/05/03 2024/05/03 HETERO LABS LTD VI Prescription
BORTEZOMIB 212782 001 NDA BORTEZOMIB SOLUTION;INTRAVENOUS, SUBCUTANEOUS 3.5MG/1.4ML (2.5MG/ML) Yes Yes 2024/08/26 2024/08/26 SHILPA Prescription
BORTEZOMIB 218688 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No No 2025/06/02 2025/06/02 VILIN BIO MED Prescription
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