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
PEPCID	019462	001	NDA	FAMOTIDINE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1986/10/15	1986/10/15	BAUSCH	Discontinued
PEPCID	019462	002	NDA	FAMOTIDINE	TABLET;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1986/10/15	1986/10/15	BAUSCH	Discontinued
PEPCID	019510	001	NDA	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1986/11/04	1986/11/04	MERCK	Discontinued
PEPCID PRESERVATIVE FREE	019510	004	NDA	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1986/11/04	1986/11/04	MERCK	Discontinued
PEPCID	019527	001	NDA	FAMOTIDINE	FOR SUSPENSION;ORAL	40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1987/02/02	1987/02/02	SALIX PHARMS	Discontinued
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	020249	001	NDA	FAMOTIDINE	INJECTABLE;INJECTION	0.4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1994/02/18	1994/02/18	MERCK SHARP DOHME	Discontinued
PEPCID AC	020325	001	NDA	FAMOTIDINE	TABLET;ORAL	10MG	Yes	No	1995/04/28	1995/04/28	KENVUE BRANDS	Over-the-counter
PEPCID AC	020325	002	NDA	FAMOTIDINE	TABLET;ORAL	20MG	Yes	Yes	1995/04/28	2003/09/23	KENVUE BRANDS	Over-the-counter
PEPCID RPD	020752	001	NDA	FAMOTIDINE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	No	No	1998/05/28	1998/05/28	MERCK	Discontinued
PEPCID RPD	020752	002	NDA	FAMOTIDINE	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	No	No	1998/05/28	1998/05/28	MERCK	Discontinued
PEPCID AC	020801	001	NDA	FAMOTIDINE	TABLET, CHEWABLE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1998/09/24	1998/09/24	KENVUE BRANDS	Discontinued
PEPCID AC	020801	002	NDA	FAMOTIDINE	TABLET, CHEWABLE;ORAL	20MG	Yes	Yes	1998/09/24	2007/12/17	KENVUE BRANDS	Over-the-counter
PEPCID AC	020902	001	NDA	FAMOTIDINE	TABLET;ORAL	10MG	No	No	1999/08/05	1999/08/05	J AND J CONSUMER INC	Over-the-counter
PEPCID COMPLETE	020958	001	NDA	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	TABLET, CHEWABLE;ORAL	800MG;10MG;165MG	Yes	Yes	2000/10/16	2000/10/16	KENVUE BRANDS	Over-the-counter