LOXITANE-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	LOXITANE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1975/02/25	Approved Prior to Jan 1, 1982	Discontinued
002	LOXITANE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	LOXITANE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	LOXITANE	LOXAPINE SUCCINATE	CAPSULE;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
006	LOXITANE	LOXAPINE SUCCINATE	TABLET;ORAL	EQ 10MG BASE Federal Register determination that product was discontinued or withdrawn for s or e reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
007	LOXITANE	LOXAPINE SUCCINATE	TABLET;ORAL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
008	LOXITANE	LOXAPINE SUCCINATE	TABLET;ORAL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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
2017/02/23	SUPPL-51（补充）	Approval	Labeling	901 REQUIRED	Label Letter
1998/09/16	SUPPL-49（补充）	Approval	Labeling	STANDARD
1997/01/28	SUPPL-48（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/03/25	SUPPL-47（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/02/27	SUPPL-46（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/06/29	SUPPL-42（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/03/29	SUPPL-41（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/12/16	SUPPL-43（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/07/25	SUPPL-40（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/07/18	SUPPL-38（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/04/28	SUPPL-37（补充）	Approval	Manufacturing (CMC)	STANDARD
1987/02/03	SUPPL-33（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/05/02	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/05/14	SUPPL-29（补充）	Approval	Manufacturing (CMC)	STANDARD
1983/10/17	SUPPL-24（补充）	Approval	Manufacturing (CMC)	STANDARD
1983/04/19	SUPPL-22（补充）	Approval	Manufacturing (CMC)	STANDARD
1983/03/10	SUPPL-21（补充）	Approval	Efficacy
1982/09/13	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
1981/10/08	SUPPL-20（补充）	Approval	Labeling
1981/10/08	SUPPL-19（补充）	Approval	Labeling
1981/01/06	SUPPL-18（补充）	Approval	Manufacturing (CMC)	STANDARD
1980/09/16	SUPPL-15（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/11/08	SUPPL-14（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/04/24	SUPPL-16（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/06/08	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/06/08	SUPPL-11（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/01/25	SUPPL-12（补充）	Approval	Labeling
1977/10/25	SUPPL-8（补充）	Approval	Labeling
1977/06/03	SUPPL-2（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/11/30	SUPPL-7（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/08/23	SUPPL-9（补充）	Approval	Labeling
1976/05/04	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/05/04	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/05/04	SUPPL-3（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/02/25	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	STANDARD