美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DABIGATRAN ETEXILATE MESYLATE"
符合检索条件的记录共 42 条
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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 MESYLATE 208057 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2017/04/19 (TA) -- TEVA PHARMS USA None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 208057 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2017/04/19 (TA) -- TEVA PHARMS USA None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 208057 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No 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 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 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2020/03/11 2024/09/11 ALKEM LABS LTD Prescription
DABIGATRAN ETEXILATE MESYLATE 207961 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2020/05/06 2020/05/06 HETERO LABS LTD III Prescription
DABIGATRAN ETEXILATE MESYLATE 207961 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2020/05/06 2020/05/06 HETERO LABS LTD III Prescription
DABIGATRAN ETEXILATE MESYLATE 207961 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2020/05/06 2024/08/13 HETERO LABS LTD III Prescription
DABIGATRAN ETEXILATE MESYLATE 207984 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2020/12/18 (TA) -- GLENMARK PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 207984 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2020/12/18 (TA) -- GLENMARK PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 207984 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2020/12/18 (TA) -- GLENMARK PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 208046 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2022/04/04 (TA) -- ALEMBIC PHARMS LTD None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE 208070 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2023/12/15 2023/12/15 APOTEX Prescription
DABIGATRAN ETEXILATE MESYLATE 208070 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2023/12/15 2023/12/15 APOTEX Prescription
DABIGATRAN ETEXILATE MESYLATE 208070 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2023/12/15 2023/12/15 APOTEX Prescription
DABIGATRAN ETEXILATE MESYLATE 213879 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2024/05/22 2024/05/22 MSN Prescription
DABIGATRAN ETEXILATE MESYLATE 213879 002 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 150MG BASE No No 2024/05/22 2024/05/22 MSN Prescription
DABIGATRAN ETEXILATE MESYLATE 213879 003 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 110MG BASE No No 2024/05/22 2024/08/12 MSN Prescription
DABIGATRAN ETEXILATE MESYLATE 215233 001 ANDA DABIGATRAN ETEXILATE MESYLATE CAPSULE;ORAL EQ 75MG BASE No No 2024/06/14 2024/06/14 ALEMBIC Prescription
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