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
ZANTAC 150	018703	001	NDA	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1983/06/09	1983/06/09	GLAXO GRP LTD	Discontinued
ZANTAC 300	018703	002	NDA	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1983/06/09	1985/12/09	GLAXO GRP LTD	Discontinued
ZANTAC	019090	001	NDA	RANITIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 25MG BASE/ML	Yes	No	1984/10/19	1984/10/19	PAI HOLDINGS PHARM	Discontinued
ZANTAC IN PLASTIC CONTAINER	019593	001	NDA	RANITIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/100ML	No	No	1986/12/17	1986/12/17	PAI HOLDINGS PHARM	Discontinued
ZANTAC IN PLASTIC CONTAINER	019593	002	NDA	RANITIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No	1986/12/17	1991/09/27	PAI HOLDINGS PHARM	Discontinued
ZANTAC	019675	001	NDA	RANITIDINE HYDROCHLORIDE	SYRUP;ORAL	EQ 15MG BASE/ML	Yes	No	1988/12/30	1988/12/30	GLAXO GRP LTD	Discontinued
ZANTAC 150	020095	001	NDA	RANITIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1994/03/08	1994/03/08	GLAXOSMITHKLINE	Discontinued
ZANTAC 300	020095	002	NDA	RANITIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1994/03/08	1994/03/08	GLAXOSMITHKLINE	Discontinued
ZANTAC 150	020251	001	NDA	RANITIDINE HYDROCHLORIDE	TABLET, EFFERVESCENT;ORAL	EQ 150MG BASE	No	No	1994/03/31	1994/03/31	GLAXO GRP LTD	Discontinued
ZANTAC 150	020251	002	NDA	RANITIDINE HYDROCHLORIDE	GRANULE, EFFERVESCENT;ORAL	EQ 150MG BASE/PACKET	No	No	1994/03/31	1994/03/31	GLAXO GRP LTD	Discontinued
ZANTAC 25	020251	003	NDA	RANITIDINE HYDROCHLORIDE	TABLET, EFFERVESCENT;ORAL	EQ 25MG BASE	No	No	1994/03/31	2004/04/01	GLAXO GRP LTD	Discontinued
ZANTAC 75	020520	001	NDA	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 75MG BASE	Yes	No	1995/12/19	1995/12/19	CHATTEM SANOFI	Discontinued
ZANTAC 75	020745	001	NDA	RANITIDINE HYDROCHLORIDE	TABLET, EFFERVESCENT;ORAL	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1998/02/26	1998/02/26	CHATTEM SANOFI	Discontinued
ZANTAC 150	021698	001	NDA	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	No	2004/08/31	2004/08/31	CHATTEM SANOFI	Discontinued
ZANTAC 150	021698	002	NDA	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	No	2004/08/31	2007/03/13	CHATTEM SANOFI	Discontinued