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
MILNACIPRAN HYDROCHLORIDE	205147	002	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	2024/10/03	2024/10/03	HETERO LABS LTD V	Prescription
MILNACIPRAN HYDROCHLORIDE	205147	003	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	2024/10/03	2024/10/03	HETERO LABS LTD V	Prescription
MILNACIPRAN HYDROCHLORIDE	205147	004	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	100MG	No	No	2024/10/03	2024/10/03	HETERO LABS LTD V	Prescription
MILNACIPRAN HYDROCHLORIDE	210944	001	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No	2026/02/12 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	210944	002	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	2026/02/12 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	210944	003	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	2026/02/12 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	210944	004	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET;ORAL	100MG	No	No	2026/02/12 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	207399	002	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET	100MG	No	No	2026/03/09 (TA)	--	STRIDES PHARMA GLOBAL PTE LIMITED	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	207399	003	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET	50MG	No	No	2026/03/09 (TA)	--	STRIDES PHARMA GLOBAL PTE LIMITED	None (Tentative Approval)
MILNACIPRAN HYDROCHLORIDE	207399	004	ANDA	MILNACIPRAN HYDROCHLORIDE	TABLET	25MG	No	No	2026/03/09 (TA)	--	STRIDES PHARMA GLOBAL PTE LIMITED	None (Tentative Approval)