CALAN-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001	CALAN	VERAPAMIL HYDROCHLORIDE	TABLET;ORAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1984/09/10	1984/09/10	Discontinued
002	CALAN	VERAPAMIL HYDROCHLORIDE	TABLET;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1984/09/10	Discontinued
003	CALAN	VERAPAMIL HYDROCHLORIDE	TABLET;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		1988/02/23	Discontinued
004	CALAN	VERAPAMIL HYDROCHLORIDE	TABLET;ORAL	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		1988/02/23	Discontinued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
2021/11/19	SUPPL-35（补充）	Approval	Labeling	STANDARD	Letter Label
2017/09/14	SUPPL-33（补充）	Approval	Labeling	STANDARD	Label Letter
2016/08/24	SUPPL-32（补充）	Approval	Labeling	STANDARD	Letter
2013/10/25	SUPPL-31（补充）	Approval	Labeling	STANDARD	Letter Label
2013/02/13	SUPPL-29（补充）	Approval	Manufacturing (CMC)	STANDARD
2011/11/02	SUPPL-27（补充）	Approval	Labeling	UNKNOWN	Letter Label
2011/06/29	SUPPL-24（补充）	Approval	Labeling	UNKNOWN	Letter Label
2010/04/13	SUPPL-22（补充）	Approval	Labeling	UNKNOWN	Letter Label
2009/07/09	SUPPL-21（补充）	Approval	Labeling	STANDARD	Letter Label
1998/01/13	SUPPL-19（补充）	Approval	Labeling	STANDARD
1996/05/14	SUPPL-18（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/02/07	SUPPL-17（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/11/04	SUPPL-16（补充）	Approval	Labeling	STANDARD
1991/09/27	SUPPL-15（补充）	Approval	Labeling
1991/08/12	SUPPL-14（补充）	Approval	Labeling
1990/02/14	SUPPL-13（补充）	Approval	Labeling
1988/04/13	SUPPL-12（补充）	Approval	Labeling
1988/02/23	SUPPL-11（补充）	Approval	Labeling
1988/02/23	SUPPL-7（补充）	Approval	Efficacy
1987/04/29	SUPPL-10（补充）	Approval	Labeling
1987/04/29	SUPPL-9（补充）	Approval	Labeling
1987/04/29	SUPPL-8（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/12/16	SUPPL-3（补充）	Approval	Efficacy
1986/10/20	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/06/27	SUPPL-6（补充）	Approval	Labeling
1986/05/06	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
1985/06/04	SUPPL-1（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/09/10	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD