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
PRONESTYL	007335	001	NDA	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1950/06/02	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	007335	002	NDA	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1950/06/02	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	007335	003	NDA	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1950/06/02	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	007335	004	NDA	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1950/06/02	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	007335	005	NDA	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1950/06/02	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	017371	001	NDA	PROCAINAMIDE HYDROCHLORIDE	TABLET;ORAL	250MG	No	No	1974/02/28	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	017371	002	NDA	PROCAINAMIDE HYDROCHLORIDE	TABLET;ORAL	375MG	No	No	1974/02/28	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL	017371	003	NDA	PROCAINAMIDE HYDROCHLORIDE	TABLET;ORAL	500MG	No	No	1974/02/28	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued
PRONESTYL-SR	087361	001	ANDA	PROCAINAMIDE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	1981/08/12	Approved Prior to Jan 1, 1982	APOTHECON	Discontinued