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
PREGABALIN	203022	004	ANDA	PREGABALIN	CAPSULE;ORAL	100MG	No	No	2014/02/21 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	203022	005	ANDA	PREGABALIN	CAPSULE;ORAL	150MG	No	No	2014/02/21 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	203022	006	ANDA	PREGABALIN	CAPSULE;ORAL	200MG	No	No	2014/02/21 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	203022	007	ANDA	PREGABALIN	CAPSULE;ORAL	225MG	No	No	2014/02/21 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	203022	008	ANDA	PREGABALIN	CAPSULE;ORAL	300MG	No	No	2014/02/21 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	202269	001	ANDA	PREGABALIN	SOLUTION;ORAL	20MG/ML	No	No	2014/10/23 (TA)	--	NOVEL LABS INC	None (Tentative Approval)
PREGABALIN	202998	001	ANDA	PREGABALIN	SOLUTION;ORAL	20MG/ML	No	No	2014/10/28 (TA)	--	APOTEX INC	None (Tentative Approval)
PREGABALIN	091221	001	ANDA	PREGABALIN	CAPSULE;ORAL	25MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	002	ANDA	PREGABALIN	CAPSULE;ORAL	50MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	003	ANDA	PREGABALIN	CAPSULE;ORAL	75MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	004	ANDA	PREGABALIN	CAPSULE;ORAL	100MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	005	ANDA	PREGABALIN	CAPSULE;ORAL	150MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	006	ANDA	PREGABALIN	CAPSULE;ORAL	200MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	007	ANDA	PREGABALIN	CAPSULE;ORAL	225MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	091221	008	ANDA	PREGABALIN	CAPSULE;ORAL	300MG	No	No	2015/04/27 (TA)	--	WATSON LABS INC	None (Tentative Approval)
PREGABALIN	205924	001	ANDA	PREGABALIN	CAPSULE;ORAL	25MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	002	ANDA	PREGABALIN	CAPSULE;ORAL	50MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	003	ANDA	PREGABALIN	CAPSULE;ORAL	75MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	004	ANDA	PREGABALIN	CAPSULE;ORAL	100MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	005	ANDA	PREGABALIN	CAPSULE;ORAL	150MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)