NAVANE-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001	NAVANE	THIOTHIXENE	CAPSULE;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1967/07/24	Approved Prior to Jan 1, 1982	Discontinued
002	NAVANE	THIOTHIXENE	CAPSULE;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	NAVANE	THIOTHIXENE	CAPSULE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
004	NAVANE	THIOTHIXENE	CAPSULE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
005	NAVANE	THIOTHIXENE	CAPSULE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	通知信、审评文件、说明书、包装标签
2010/12/01	SUPPL-60（补充）	Approval	Labeling	901 REQUIRED	Letter Label
2009/07/19	SUPPL-59（补充）	Approval	Labeling	901 REQUIRED	Letter Label
2008/08/14	SUPPL-58（补充）	Approval	Labeling	STANDARD	Letter Label
2008/04/07	SUPPL-57（补充）	Approval	Labeling	STANDARD	Letter Label
2003/05/19	SUPPL-56（补充）	Approval	Labeling	STANDARD	Label
2001/07/31	SUPPL-55（补充）	Approval	Labeling	STANDARD	Letter
2001/07/31	SUPPL-47（补充）	Approval	Labeling	STANDARD	Letter Label
2001/02/28	SUPPL-54（补充）	Approval	Manufacturing (CMC)	STANDARD
2000/03/27	SUPPL-52（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/07/26	SUPPL-51（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/06/26	SUPPL-45（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/06/21	SUPPL-44（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/12/10	SUPPL-42（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/09/24	SUPPL-37（补充）	Approval	Manufacturing (CMC)	STANDARD
1981/05/21	SUPPL-39（补充）	Approval	Manufacturing (CMC)	STANDARD
1981/03/10	SUPPL-38（补充）	Approval	Manufacturing (CMC)	STANDARD
1980/12/10	SUPPL-36（补充）	Approval	Labeling
1980/10/08	SUPPL-35（补充）	Approval	Manufacturing (CMC)	STANDARD
1980/09/15	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/10/03	SUPPL-33（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/12/11	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/12/08	SUPPL-29（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/07/07	SUPPL-28（补充）	Approval	Labeling
1978/07/07	SUPPL-27（补充）	Approval	Manufacturing (CMC)	STANDARD
1977/02/18	SUPPL-25（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/07/29	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/05/01	SUPPL-22（补充）	Approval	Manufacturing (CMC)	STANDARD
1974/06/24	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
1967/07/24	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	STANDARD