TAVIST-美国FDA药品数据库-药物在线

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001	TAVIST	CLEMASTINE FUMARATE	TABLET;ORAL	2.68MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1977/02/25	Approved Prior to Jan 1, 1982	Discontinued
002	TAVIST-1	CLEMASTINE FUMARATE	TABLET;ORAL	1.34MG	No	No	None	Approved Prior to Jan 1, 1982	Discontinued
003	TAVIST-1	CLEMASTINE FUMARATE	TABLET;ORAL	1.34MG	No	No	None	1992/08/21	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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签	备注
1977/02/25	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	STANDARD

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	审评优先级；罕用药状态
2002/02/11	SUPPL-51（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/10/31	SUPPL-48（补充）	Approval	Efficacy-New Indication	STANDARD
1996/06/06	SUPPL-49（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1995/11/07	SUPPL-45（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1995/10/20	SUPPL-47（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/10/17	SUPPL-46（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1995/02/03	SUPPL-43（补充）	Approval	Labeling	STANDARD
1994/07/21	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1994/06/08	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1993/05/21	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1993/04/22	SUPPL-40（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1992/09/08	SUPPL-34（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1992/09/04	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1992/08/21	SUPPL-26（补充）	Approval	Efficacy-Rx To OTC Switch	STANDARD
1992/08/07	SUPPL-38（补充）	Approval	Labeling	STANDARD
1992/07/22	SUPPL-36（补充）	Approval	Labeling	STANDARD
1992/04/23	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/03/04	SUPPL-32（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/02/21	SUPPL-35（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1987/12/04	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/04/16	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/04/15	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1983/03/01	SUPPL-23（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/07/17	SUPPL-21（补充）	Approval	Manufacturing (CMC)	STANDARD
1981/07/15	SUPPL-22（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/10/14	SUPPL-14（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/05/01	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/04/17	SUPPL-17（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/04/01	SUPPL-18（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/04/20	SUPPL-16（补充）	Approval	Labeling	STANDARD
1979/04/20	SUPPL-15（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/03/16	SUPPL-6（补充）	Approval	Labeling	STANDARD
1979/03/16	SUPPL-5（补充）	Approval	Efficacy	STANDARD
1979/03/16	SUPPL-2（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD
1978/08/17	SUPPL-13（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1978/08/14	SUPPL-11（补充）	Approval	Labeling	STANDARD
1978/08/14	SUPPL-10（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1978/08/11	SUPPL-12（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1978/05/30	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1978/05/30	SUPPL-8（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1978/05/24	SUPPL-7（补充）	Approval	Labeling	STANDARD
1978/02/16	SUPPL-4（补充）	Approval	Labeling	STANDARD
1978/02/16	SUPPL-3（补充）	Approval	Manufacturing (CMC)-Formulation	STANDARD