美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DABIGATRAN ETEXILATE"
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
DABIGATRAN ETEXILATE 207984 002 ANDA DABIGATRAN ETEXILATE CAPSULE;ORAL 110MG No 2017/04/18 (TA) GLENMARK PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE 207984 003 ANDA DABIGATRAN ETEXILATE CAPSULE;ORAL 150MG No 2017/04/18 (TA) GLENMARK PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE 208057 002 ANDA DABIGATRAN ETEXILATE CAPSULE;ORAL 110MG No 2017/04/19 (TA) TEVA PHARMS USA None (Tentative Approval)
DABIGATRAN ETEXILATE 208057 003 ANDA DABIGATRAN ETEXILATE CAPSULE;ORAL 150MG No 2017/04/19 (TA) TEVA PHARMS USA None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 208040 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2020/03/11 2020/03/11 ALKEM LABS LTD Prescription
DABIGATRAN ETEXILATE MESYLATE 208040 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2020/03/11 (TA) 2020/03/11 ALKEM LABS LTD Prescription
DABIGATRAN ETEXILATE MESYLATE 208040 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2020/03/11 2020/03/11 ALKEM LABS LTD Prescription
DABIGATRAN ETEXILATE MESYLATE 208040 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2020/03/11 (TA) 2020/03/11 ALKEM LABS LTD Prescription
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