SERENTIL-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	SERENTIL	MESORIDAZINE BESYLATE	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None	1970/02/27	Approved Prior to Jan 1, 1982	Discontinued
002	SERENTIL	MESORIDAZINE BESYLATE	TABLET;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	SERENTIL	MESORIDAZINE BESYLATE	TABLET;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		Approved Prior to Jan 1, 1982	Discontinued
004	SERENTIL	MESORIDAZINE BESYLATE	TABLET;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		Approved Prior to Jan 1, 1982	Discontinued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
2001/07/06	SUPPL-74（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/03/28	SUPPL-75（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/03/15	SUPPL-73（补充）	Approval	Labeling	STANDARD	Review Letter
2000/09/06	SUPPL-72（补充）	Approval	Labeling	STANDARD
1997/03/14	SUPPL-71（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/11/22	SUPPL-70（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/10/17	SUPPL-69（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/08/01	SUPPL-66（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/07/01	SUPPL-61（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/11/30	SUPPL-62（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/03/14	SUPPL-56（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/11/03	SUPPL-59（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/08/15	SUPPL-58（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/05/10	SUPPL-57（补充）	Approval	Manufacturing (CMC)	STANDARD
1987/08/20	SUPPL-54（补充）	Approval	Manufacturing (CMC)	STANDARD
1987/05/26	SUPPL-53（补充）	Approval	Manufacturing (CMC)	STANDARD
1987/04/23	SUPPL-52（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/10/17	SUPPL-45（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/03/24	SUPPL-50（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/10/23	SUPPL-49（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/05/08	SUPPL-47（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/03/14	SUPPL-46（补充）	Approval	Manufacturing (CMC)	STANDARD
1983/01/19	SUPPL-42（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/11/05	SUPPL-43（补充）	Approval	Labeling	STANDARD
1981/06/22	SUPPL-41（补充）	Approval	Manufacturing (CMC)	STANDARD
1981/03/24	SUPPL-39（补充）	Approval	Manufacturing (CMC)	STANDARD
1980/12/10	SUPPL-38（补充）	Approval	Labeling	STANDARD
1980/03/07	SUPPL-37（补充）	Approval	Manufacturing (CMC)	STANDARD
1980/01/16	SUPPL-36（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/08/30	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/04/04	SUPPL-35（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/12/08	SUPPL-32（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/06/12	SUPPL-33（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/01/24	SUPPL-29（补充）	Approval	Manufacturing (CMC)	STANDARD
1977/06/03	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
1977/06/03	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/09/15	SUPPL-28（补充）	Approval	Labeling	STANDARD
1976/08/03	SUPPL-26（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/07/16	SUPPL-25（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/05/25	SUPPL-27（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/12/02	SUPPL-24（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/07/01	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/05/06	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/03/31	SUPPL-19（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/01/30	SUPPL-15（补充）	Approval	Manufacturing (CMC)	STANDARD
1974/06/07	SUPPL-18（补充）	Approval	Manufacturing (CMC)	STANDARD
1970/02/27	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	STANDARD