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
METFORMIN HYDROCHLORIDE	209993	001	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	2018/12/27	2018/12/27	QINGDAO BAHEAL PHARM	Prescription
METFORMIN HYDROCHLORIDE	209993	002	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No	2018/12/27	2018/12/27	QINGDAO BAHEAL PHARM	Prescription
METFORMIN HYDROCHLORIDE	212969	001	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	2019/11/25	2019/11/25	GLENMARK PHARMS LTD	Prescription
METFORMIN HYDROCHLORIDE	212969	002	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No	2019/11/25	2019/11/25	GLENMARK PHARMS LTD	Prescription
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	210212	001	ANDA	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET; ORAL	12.5MG/500MG	No	No	2019/11/27 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	210212	002	ANDA	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET; ORAL	12.5MG/1000MG	No	No	2019/11/27 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE	211309	001	ANDA	METFORMIN HYDROCHLORIDE	SOLUTION;ORAL	500MG/5ML	No	Yes	2020/03/03	2020/03/03	SAPTALIS PHARMS	Prescription
METFORMIN HYDROCHLORIDE	213651	001	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	2020/04/09	2020/04/09	AJANTA PHARMA LTD	Prescription
METFORMIN HYDROCHLORIDE	213651	002	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No	2020/04/09	2020/04/09	AJANTA PHARMA LTD	Prescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208454	001	ANDA	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET; ORAL	2.5MG/500MG	No	No	2020/05/28 (TA)	--	SUN PHARM INDS LTD	None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208454	002	ANDA	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET; ORAL	2.5MG/850MG	No	No	2020/05/28 (TA)	--	SUN PHARM INDS LTD	None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208454	003	ANDA	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET; ORAL	2.5MG/1GM	No	No	2020/05/28 (TA)	--	SUN PHARM INDS LTD	None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	213654	001	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG; 1GM	No	No	2021/01/06 (TA)	--	LUPIN LTD	None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	213654	002	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG; 1GM	No	No	2021/01/06 (TA)	--	LUPIN LTD	None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	213654	003	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG; 1GM	No	No	2021/01/06 (TA)	--	LUPIN LTD	None (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	213654	004	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG; 1GM	No	No	2021/01/06 (TA)	--	LUPIN LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE	213344	001	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	2021/01/14	2021/01/12	GRANULES	Prescription
METFORMIN HYDROCHLORIDE	213344	002	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No	2021/01/14	2021/01/12	GRANULES	Prescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208427	001	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG; 500MG	No	No	2021/02/01 (TA)	--	DR REDDYS LABS LTD	None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208427	002	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG; 850MG	No	No	2021/02/01 (TA)	--	DR REDDYS LABS LTD	None (Tentative Approval)