美国FDA药品数据库-药物在线

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	No	2015/05/18 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	205057	001	ANDA	TAPENTADOL	TABLET;ORAL	50MG	No	No	2015/05/19 (TA)	--	ROXANE	None (Tentative Approval)
TAPENTADOL	205057	002	ANDA	TAPENTADOL	TABLET;ORAL	75MG	No	No	2015/05/19 (TA)	--	ROXANE	None (Tentative Approval)
TAPENTADOL	205057	003	ANDA	TAPENTADOL	TABLET;ORAL	100MG	No	No	2015/05/19 (TA)	--	ROXANE	None (Tentative Approval)
TAPENTADOL	205015	001	ANDA	TAPENTADOL	TABLET;ORAL	50MG	No	No	2016/03/31 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
TAPENTADOL	205015	002	ANDA	TAPENTADOL	TABLET;ORAL	75MG	No	No	2016/03/31 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
TAPENTADOL	205015	003	ANDA	TAPENTADOL	TABLET;ORAL	100MG	No	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	No	2016/03/31 (TA)	--	ACTAVIS LABS UT INC	None (Tentative Approval)
TAPENTADOL	204972	001	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No	2017/05/24 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	204972	002	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No	2017/05/24 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	204972	003	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No	2017/05/24 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	204972	004	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No	2017/05/24 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	204972	005	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	250MG	No	No	2017/05/24 (TA)	--	ACTAVIS ELIZABETH	None (Tentative Approval)
TAPENTADOL	206418	002	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No	2017/05/25 (TA)	--	WEST-WARD PHARMS INT	None (Tentative Approval)
TAPENTADOL	206418	003	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	150MG	No	No	2017/05/25 (TA)	--	WEST-WARD PHARMS INT	None (Tentative Approval)
TAPENTADOL	206418	004	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No	2017/05/25 (TA)	--	WEST-WARD PHARMS INT	None (Tentative Approval)
TAPENTADOL	206418	005	ANDA	TAPENTADOL	TABLET, EXTENDED RELEASE;ORAL	250MG	No	No	2017/05/25 (TA)	--	WEST-WARD PHARMS INT	None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE	209369	002	ANDA	TAPENTADOL HYDROCHLORIDE	TABLET;ORAL	75MG	No	No	2017/09/14 (TA)	--	RHODES PHARMS	None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE	209369	003	ANDA	TAPENTADOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No	2017/09/14 (TA)	--	RHODES PHARMS	None (Tentative Approval)
TAPENTADOL HYDROCHLORIDE	214378	002	ANDA	TAPENTADOL HYDROCHLORIDE	TABLET; ORAL	EQ 75MG BASE	No	No	2022/04/28 (TA)	--	HUMANWELL PHARMACEUTICAL US INC	None (Tentative Approval)