美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PRADAXA"
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
PRADAXA 022512 001 NDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE Yes No 2010/10/19 2010/10/19 BOEHRINGER INGELHEIM Prescription
PRADAXA 022512 002 NDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE Yes Yes 2010/10/19 2010/10/19 BOEHRINGER INGELHEIM Prescription
PRADAXA 022512 003 NDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE Yes No 2010/10/19 2015/11/20 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 001 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 20MG BASE/PACKET Yes No 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 002 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 30MG BASE/PACKET Yes No 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 003 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 40MG BASE/PACKET Yes No 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 004 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 50MG BASE/PACKET Yes No 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 005 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 110MG BASE/PACKET Yes No 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
PRADAXA 214358 006 NDA DABIGATRAN ETEXILATE MESYLATE PELLETS;ORAL EQ 150MG BASE/PACKET Yes Yes 2021/06/21 2021/06/21 BOEHRINGER INGELHEIM Prescription
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