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
DONEPEZIL HYDROCHLORIDE	203162	001	ANDA	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	23MG	No	No	2017/08/31	2017/08/31	ZYDUS PHARMS	Prescription
DONEPEZIL HYDROCHLORIDE	204609	001	ANDA	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No	2017/09/19	2017/09/19	CADILA PHARMS LTD	Prescription
DONEPEZIL HYDROCHLORIDE	204609	002	ANDA	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	10MG	No	No	2017/09/19	2017/09/19	CADILA PHARMS LTD	Prescription
DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE	208672	002	ANDA	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG;28MG	No	No	2017/10/10 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
DONEPEZIL HYDROCHLORIDE	205269	001	ANDA	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	No	No	2018/07/27	2018/07/27	HISUN PHARM HANGZHOU	Prescription
DONEPEZIL HYDROCHLORIDE	205269	002	ANDA	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No	2018/07/27	2018/07/27	HISUN PHARM HANGZHOU	Prescription
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	208237	001	ANDA	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG;21MG	No	No	2023/12/15	2023/12/15	ANI PHARMS	Prescription
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	208237	001	ANDA	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG;21MG	No	No	2023/12/15 (TA)	2023/12/15	ANI PHARMS	Prescription
MEMANTINE;DONEPEZIL HYDROCHLORIDES	216901	001	ANDA	MEMANTINE;DONEPEZIL HYDROCHLORIDES	CAPSULE, EXTENDED RELEASE;ORAL	14MG;10MG	No	No	2024/05/01 (TA)	--	XIAMEN LP PHARM CO	None (Tentative Approval)
MEMANTINE;DONEPEZIL HYDROCHLORIDES	216901	002	ANDA	MEMANTINE;DONEPEZIL HYDROCHLORIDES	CAPSULE, EXTENDED RELEASE;ORAL	28MG;10MG	No	No	2024/05/01 (TA)	--	XIAMEN LP PHARM CO	None (Tentative Approval)