URECHOLINE-美国FDA药品数据库-药物在线

产品信息

产品号	商品名	活性成分	剂型/给药途径	规格/剂量	参比药物(RLD)	生物等效参考标准(RS)	治疗等效代码	该申请号批准日期	该产品号批准日期	市场状态
001	URECHOLINE	BETHANECHOL CHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1948/10/12	Approved Prior to Jan 1, 1982	Discontinued
002	URECHOLINE	BETHANECHOL CHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	URECHOLINE	BETHANECHOL CHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
004	URECHOLINE	BETHANECHOL CHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
005	URECHOLINE	BETHANECHOL CHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued

批准日期，申请提交历史，通知信，药品说明书，审评文件等信息

提交状态日期	提交号	审批结论	申请内容分类	审评优先级；罕用药状态
1998/04/02	SUPPL-38（补充）	Approval	Labeling	STANDARD
1998/03/31	SUPPL-42（补充）	Approval	Manufacturing (CMC)
1998/01/20	SUPPL-43（补充）	Approval	Manufacturing (CMC)
1997/08/14	SUPPL-41（补充）	Approval	Manufacturing (CMC)
1996/09/03	SUPPL-40（补充）	Approval	Manufacturing (CMC)
1996/03/11	SUPPL-39（补充）	Approval	Manufacturing (CMC)
1995/09/11	SUPPL-37（补充）	Approval	Manufacturing (CMC)
1993/08/09	SUPPL-36（补充）	Approval	Labeling
1992/08/28	SUPPL-35（补充）	Approval	Manufacturing (CMC)
1987/03/09	SUPPL-34（补充）	Approval	Labeling
1985/09/12	SUPPL-33（补充）	Approval	Manufacturing (CMC)
1985/07/03	SUPPL-32（补充）	Approval	Manufacturing (CMC)
1985/01/14	SUPPL-28（补充）	Approval	Labeling
1984/10/24	SUPPL-30（补充）	Approval	Manufacturing (CMC)
1984/10/11	SUPPL-31（补充）	Approval	Manufacturing (CMC)
1983/09/16	SUPPL-29（补充）	Approval	Manufacturing (CMC)
1981/11/03	SUPPL-26（补充）	Approval	Manufacturing (CMC)
1981/07/14	SUPPL-27（补充）	Approval	Manufacturing (CMC)
1981/06/17	SUPPL-25（补充）	Approval	Manufacturing (CMC)
1980/12/22	SUPPL-24（补充）	Approval	Manufacturing (CMC)
1980/06/24	SUPPL-21（补充）	Approval	Labeling
1980/05/29	SUPPL-22（补充）	Approval	Manufacturing (CMC)
1980/05/01	SUPPL-23（补充）	Approval	Labeling
1980/05/01	SUPPL-18（补充）	Approval	Labeling
1980/05/01	SUPPL-17（补充）	Approval	Labeling
1979/08/13	SUPPL-20（补充）	Approval	Labeling
1978/10/02	SUPPL-16（补充）	Approval	Labeling
1977/12/12	SUPPL-15（补充）	Approval	Manufacturing (CMC)
1977/09/19	SUPPL-14（补充）	Approval	Labeling
1976/05/17	SUPPL-13（补充）	Approval	Labeling
1976/05/17	SUPPL-12（补充）	Approval	Manufacturing (CMC)
1948/10/12	ORIG-1（原始申请）	Approval		UNKNOWN