CARDIZEM SR-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	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1989/01/23	1989/01/23	Discontinued
002	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1989/01/23	Discontinued
003	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1989/01/23	Discontinued
004	CARDIZEM SR	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1989/01/23	Discontinued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
2003/03/21	SUPPL-29（补充）	Approval	Labeling	STANDARD
2001/06/04	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
1999/12/06	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
1998/12/03	SUPPL-28（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/11/20	SUPPL-27（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/08/05	SUPPL-26（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/05/28	SUPPL-24（补充）	Approval	Labeling	STANDARD
1996/05/16	SUPPL-25（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/04/03	SUPPL-19（补充）	Approval	Manufacturing (CMC)	STANDARD
1995/03/17	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/09/14	SUPPL-21（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/09/14	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/03/18	SUPPL-18（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/03/15	SUPPL-17（补充）	Approval	Manufacturing (CMC)	STANDARD
1993/08/02	SUPPL-16（补充）	Approval	Manufacturing (CMC)	STANDARD
1993/04/01	SUPPL-15（补充）	Approval	Labeling	STANDARD
1992/10/22	SUPPL-14（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/10/22	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/07/01	SUPPL-10（补充）	Approval	Labeling	STANDARD
1991/06/13	SUPPL-11（补充）	Approval	Labeling	STANDARD
1991/05/03	SUPPL-6（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/01/07	SUPPL-8（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/09/14	SUPPL-7（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/08/16	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/07/27	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/04/23	SUPPL-2（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/03/08	SUPPL-1（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/01/23	ORIG-1（原始申请）	Approval	Type 3 - New Dosage Form	STANDARD