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
ALOXI	021372	001	NDA	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/07/25	2003/07/25	HELSINN HLTHCARE	Discontinued
ALOXI	021372	002	NDA	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2003/07/25	2008/02/29	HELSINN HLTHCARE	Discontinued
ALOXI	022233	001	NDA	PALONOSETRON HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/08/22	2008/08/22	HELSINN HLTHCARE	Discontinued
RALOXIFENE HYDROCHLORIDE	078193	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2014/03/04	2014/03/04	TEVA PHARMS USA	Prescription
RALOXIFENE HYDROCHLORIDE	090842	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2014/09/24	2014/09/24	INVAGEN PHARMS	Prescription
RALOXIFENE HYDROCHLORIDE	200825	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2015/01/21	2015/01/21	WATSON LABS INC	Prescription
RALOXIFENE HYDROCHLORIDE	204310	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2015/08/28	2015/08/28	AUROBINDO PHARMA	Prescription
RALOXIFENE HYDROCHLORIDE	204491	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2016/03/22	2016/03/22	GLENMARK PHARMS LTD	Prescription
RALOXIFENE HYDROCHLORIDE	208206	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2016/04/08	2016/04/08	AMNEAL PHARMS	Prescription
RALOXIFENE HYDROCHLORIDE	206384	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2016/10/12	2016/10/12	SCIEGEN PHARMS INC	Prescription
RALOXIFENE HYDROCHLORIDE	211324	001	ANDA	RALOXIFENE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No	2020/08/18	2020/08/18	CADILA PHARMS LTD	Prescription