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
DITROPAN	017577	001	NDA	OXYBUTYNIN CHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1975/07/16	Approved Prior to Jan 1, 1982	JANSSEN PHARMS	Discontinued
DITROPAN	018211	001	NDA	OXYBUTYNIN CHLORIDE	SYRUP;ORAL	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1979/11/29	Approved Prior to Jan 1, 1982	ORTHO MCNEIL JANSSEN	Discontinued
DITROPAN XL	020897	001	NDA	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1998/12/16	1998/12/16	JANSSEN PHARMS	Discontinued
DITROPAN XL	020897	002	NDA	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1998/12/16	1998/12/16	JANSSEN PHARMS	Discontinued
DITROPAN XL	020897	003	NDA	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1998/12/16	1999/06/22	JANSSEN PHARMS	Discontinued