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
EZETIMIBE AND SIMVASTATIN	200082	004	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;80MG	No	No	2020/12/17	2020/12/17	AUROBINDO PHARMA USA	Prescription
EZETIMIBE	210859	001	ANDA	EZETIMIBE	TABLET;ORAL	10MG	No	No	2022/07/26	2022/07/26	HETERO LABS LTD III	Prescription
EZETIMIBE	215693	001	ANDA	EZETIMIBE	TABLET;ORAL	10MG	No	No	2022/09/13	2022/09/13	ORIENT PHARMA	Prescription
EZETIMIBE	211159	001	ANDA	EZETIMIBE	TABLET;ORAL	10MG	No	No	2024/04/29	2024/04/29	MACLEODS PHARMS LTD	Discontinued
EZETIMIBE AND SIMVASTATIN	211663	001	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;10MG	No	No	2024/12/10	2024/12/10	SCIEGEN PHARMS INC	Discontinued
EZETIMIBE AND SIMVASTATIN	211663	002	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;20MG	No	No	2024/12/10	2024/12/10	SCIEGEN PHARMS INC	Discontinued
EZETIMIBE AND SIMVASTATIN	211663	003	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;40MG	No	No	2024/12/10	2024/12/10	SCIEGEN PHARMS INC	Discontinued
EZETIMIBE AND SIMVASTATIN	211663	004	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;80MG	No	No	2024/12/10	2024/12/10	SCIEGEN PHARMS INC	Discontinued
EZETIMIBE AND SIMVASTATIN	209461	001	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;10MG	No	No	2025/01/27	2025/01/27	TORRENT	Discontinued
EZETIMIBE AND SIMVASTATIN	209461	002	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;20MG	No	No	2025/01/27	2025/01/27	TORRENT	Discontinued
EZETIMIBE AND SIMVASTATIN	209461	003	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;40MG	No	No	2025/01/27	2025/01/27	TORRENT	Discontinued
EZETIMIBE AND SIMVASTATIN	209461	004	ANDA	EZETIMIBE; SIMVASTATIN	TABLET;ORAL	10MG;80MG	No	No	2025/01/27	2025/01/27	TORRENT	Discontinued
BEMPEDOIC ACID AND EZETIMIBE	219421	002	ANDA	BEMPEDOIC ACID, EZETIMIBE	TABLET	180MG	No	No	2025/10/23 (TA)	--	ALKEM LABORATORIES LIMITED	None (Tentative Approval)