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	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)
BALSALAZIDE DISODIUM	206909	001	ANDA	BALSALAZIDE DISODIUM	TABLET;ORAL	1.1G	No	No	2015/09/01 (TA)	--	MYLAN PHARMS INC	None (Tentative Approval)
BALSALAZIDE DISODIUM	206336	001	ANDA	BALSALAZIDE DISODIUM	TABLET;ORAL	1.1GM	No	No	2015/09/08	2015/09/08	STRIDES PHARMA	Discontinued
CYANOCOBALAMIN	206503	001	ANDA	CYANOCOBALAMIN	INJECTABLE;INJECTION	1MG/ML	No	No	2015/12/11	2015/12/11	SOMERSET THERAPS LLC	Prescription
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)
PREGABALIN	205924	006	ANDA	PREGABALIN	CAPSULE;ORAL	200MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	007	ANDA	PREGABALIN	CAPSULE;ORAL	225MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
PREGABALIN	205924	008	ANDA	PREGABALIN	CAPSULE;ORAL	300MG	No	No	2016/05/18 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
BALSALAZIDE DISODIUM	206529	001	ANDA	BALSALAZIDE DISODIUM	TABLET;ORAL	1.1GM	No	No	2016/12/28 (TA)	--	LUPIN LTD	None (Tentative Approval)
CYANOCOBALAMIN	204829	001	ANDA	CYANOCOBALAMIN	INJECTABLE;INJECTION	1MG/ML	No	No	2017/06/05	2017/06/05	MYLAN LABS LTD	Prescription
BALCOLTRA	208612	001	NDA	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL	0.02MG;0.1MG	Yes	Yes	2018/01/09	2018/01/09	AVION PHARMS	Prescription