美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TAPENTADOL"
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
TAPENTADOL 204971 001 ANDA TAPENTADOL TABLET;ORAL 50MG No 2015/05/18 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 205057 001 ANDA TAPENTADOL TABLET;ORAL 50MG No 2015/05/19 (TA) ROXANE None (Tentative Approval)
TAPENTADOL 205057 002 ANDA TAPENTADOL TABLET;ORAL 75MG No 2015/05/19 (TA) ROXANE None (Tentative Approval)
TAPENTADOL 205057 003 ANDA TAPENTADOL TABLET;ORAL 100MG No 2015/05/19 (TA) ROXANE None (Tentative Approval)
TAPENTADOL 205015 001 ANDA TAPENTADOL TABLET;ORAL 50MG No 2016/03/31 (TA) ALKEM LABS LTD None (Tentative Approval)
TAPENTADOL 205015 002 ANDA TAPENTADOL TABLET;ORAL 75MG No 2016/03/31 (TA) ALKEM LABS LTD None (Tentative Approval)
TAPENTADOL 205015 003 ANDA TAPENTADOL TABLET;ORAL 100MG No 2016/03/31 (TA) ALKEM LABS LTD None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE 206657 001 ANDA TAPENTADOL HYDROCHLORIDE SOLUTION;ORAL EQ 20MG BASE/ML No 2016/03/31 (TA) ACTAVIS LABS UT INC None (Tentative Approval)
TAPENTADOL 204972 001 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 50MG No 2017/05/24 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 204972 002 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 100MG No 2017/05/24 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 204972 003 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 150MG No 2017/05/24 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 204972 004 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 200MG No 2017/05/24 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 204972 005 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 250MG No 2017/05/24 (TA) ACTAVIS ELIZABETH None (Tentative Approval)
TAPENTADOL 206418 002 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 100MG No 2017/05/25 (TA) WEST-WARD PHARMS INT None (Tentative Approval)
TAPENTADOL 206418 003 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 150MG No 2017/05/25 (TA) WEST-WARD PHARMS INT None (Tentative Approval)
TAPENTADOL 206418 004 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 200MG No 2017/05/25 (TA) WEST-WARD PHARMS INT None (Tentative Approval)
TAPENTADOL 206418 005 ANDA TAPENTADOL TABLET, EXTENDED RELEASE;ORAL 250MG No 2017/05/25 (TA) WEST-WARD PHARMS INT None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE 209369 002 ANDA TAPENTADOL HYDROCHLORIDE TABLET;ORAL 75MG No 2017/09/14 (TA) RHODES PHARMS None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE 209369 003 ANDA TAPENTADOL HYDROCHLORIDE TABLET;ORAL 100MG No 2017/09/14 (TA) RHODES PHARMS None (Tentative Approval)
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