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 208645 001 NDA BORTEZOMIB INJECTABLE; INJECTION 2.5MG/ML No 2016/10/20 (TA) ACTAVIS LLC None (Tentative Approval)
BORTEZOMIB 208645 002 NDA BORTEZOMIB INJECTABLE; INJECTION 3.5MG/1.4ML No 2016/10/20 (TA) ACTAVIS LLC None (Tentative Approval)
BORTEZOMIB 204405 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No 2017/04/24 (TA) ACCORD HLTHCARE INC None (Tentative Approval)
BORTEZOMIB 208392 001 ANDA BORTEZOMIB INJECTABLE;INJECTION 3.5MG/VIAL No 2017/05/03 (TA) PHARMASCIENCE INC None (Tentative Approval)
BORTEZOMIB 205533 001 ANDA BORTEZOMIB VIAL 3.5MG/VIAL No 2017/05/12 (TA) APOTEX INC None (Tentative Approval)
BORTEZOMIB 205004 001 NDA BORTEZOMIB POWDER;INTRAVENOUS 3.5MG/VIAL No No 2017/11/06 2017/11/06 FRESENIUS KABI USA Prescription
BORTEZOMIB 209191 001 NDA BORTEZOMIB POWDER;INTRAVENOUS, SUBCUTANEOUS 2.5MG/VIAL Yes No 2018/07/12 2018/07/12 HOSPIRA INC Discontinued
BORTEZOMIB 209191 002 NDA BORTEZOMIB POWDER;INTRAVENOUS, SUBCUTANEOUS 1MG/VIAL Yes No 2018/07/12 2018/12/28 HOSPIRA INC Discontinued
BORTEZOMIB 210824 001 ANDA BORTEZOMIB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 3.5MG/VIAL No 2018/11/09 (TA) QILU PHARM CO LTD None (Tentative Approval)
BORTEZOMIB 206927 001 NDA BORTEZOMIB POWDER;INTRAVENOUS 3.5MG/VIAL No No 2019/10/04 2019/10/04 DR REDDYS LABS LTD Prescription
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