美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=BIVALIRUDIN"
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
BIVALIRUDIN 090811 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2015/07/14 2015/07/14 HOSPIRA INC Prescription
BIVALIRUDIN 090816 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2015/07/14 2015/07/14 HOSPIRA INC Prescription
BIVALIRUDIN 091206 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No 2016/09/14 (TA) PLIVA HRVATSKA DOO None (Tentative Approval)
BIVALIRUDIN 090189 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2016/10/28 2016/10/28 FRESENIUS KABI USA Prescription
BIVALIRUDIN 091468 001 ANDA BIVALIRUDIN INJECTABLE;INJECTION 250MG/VIAL No 2017/02/02 (TA) MYLAN LABS LTD None (Tentative Approval)
BIVALIRUDIN 201577 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2017/05/26 2017/05/26 DR REDDYS LABS LTD Prescription
BIVALIRUDIN 204876 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2017/07/06 2017/07/06 APOTEX Discontinued
BIVALIRUDIN 206551 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2017/11/22 2017/11/22 ACCORD HLTHCARE Prescription
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 208374 001 NDA BIVALIRUDIN SOLUTION;INTRAVENOUS 250MG/50ML (5MG/ML) Yes Yes 2017/12/21 2017/12/21 BAXTER HLTHCARE CORP Prescription
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 208374 002 NDA BIVALIRUDIN SOLUTION;INTRAVENOUS 500MG/100ML (5MG/ML) Yes Yes 2017/12/21 2017/12/21 BAXTER HLTHCARE CORP Prescription
BIVALIRUDIN 202471 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2018/06/01 2018/06/01 MYLAN INSTITUTIONAL Prescription
BIVALIRUDIN 091602 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2018/07/16 2018/07/16 CIPLA Prescription
BIVALIRUDIN 205962 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2018/07/27 2018/07/27 AUROBINDO PHARMA LTD Prescription
BIVALIRUDIN 210031 001 ANDA BIVALIRUDIN INJECTABLE;INTRAVENOUS 250MG/VIAL No No 2019/10/23 2019/10/23 SHUANGCHENG Prescription
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