SORIATANE-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001	SORIATANE	ACITRETIN	CAPSULE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1996/10/28	1996/10/28	Discontinued
002	SORIATANE	ACITRETIN	CAPSULE;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1996/10/28	Discontinued
003	SORIATANE	ACITRETIN	CAPSULE;ORAL	17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		2009/08/06	Discontinued
004	SORIATANE	ACITRETIN	CAPSULE;ORAL	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		2009/08/06	Discontinued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
2023/02/22	SUPPL-29（补充）	Approval	Labeling	STANDARD	Letter Label Medication Guide
2017/09/27	SUPPL-28（补充）	Approval	Labeling	STANDARD	Label Letter
2015/05/19	SUPPL-27（补充）	Approval	Labeling	STANDARD	Letter Label
2014/10/28	SUPPL-25（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/05/13	SUPPL-24（补充）	Approval	Labeling	STANDARD	Letter Label
2014/02/18	SUPPL-22（补充）	Approval	Labeling	STANDARD	Letter Label
2014/01/30	SUPPL-23（补充）	Approval	Labeling	STANDARD	Letter Label
2011/11/25	SUPPL-18（补充）	Approval	Labeling	UNKNOWN	Letter Label Medication Guide
2009/08/06	SUPPL-17（补充）	Approval	Labeling	STANDARD	Letter
2007/10/18	SUPPL-15（补充）	Approval	Labeling	STANDARD	Letter Label
2007/10/18	SUPPL-14（补充）	Approval	Labeling	STANDARD	Letter Label
2004/11/04	SUPPL-12（补充）	Approval	Labeling	STANDARD	Letter
2004/10/08	SUPPL-11（补充）	Approval	Labeling	STANDARD	Letter Label
2004/03/22	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD	Letter Label
2003/04/18	SUPPL-6（补充）	Approval	Labeling	STANDARD	Letter Label Review
2003/04/18	SUPPL-2（补充）	Approval	Labeling	STANDARD	Review Letter Label
2003/01/03	SUPPL-7（补充）	Approval	Manufacturing (CMC)	STANDARD
2002/09/12	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/01/11	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1999/12/30	SUPPL-3（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/06/05	SUPPL-1（补充）	Approval	Labeling	STANDARD	Review
1996/10/28	ORIG-1（原始申请）	Approval	Type 2 - New Active Ingredient	STANDARD