CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER-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	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 6MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1989/08/30	1989/08/30	Discontinued
002	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 12MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1989/08/30	Discontinued
003	CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	INJECTABLE;INJECTION	EQ 18MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1991/04/10	Discontinued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	备注
2022/05/20	SUPPL-42（补充）	Approval	Labeling	STANDARD	Letter Label
2021/12/04	SUPPL-43（补充）	Approval	Labeling	STANDARD	Label Letter
2020/03/04	SUPPL-41（补充）	Approval	Labeling	STANDARD	Letter Label
2019/06/19	SUPPL-40（补充）	Approval	Labeling	STANDARD	Label Letter
2018/04/16	SUPPL-38（补充）	Approval	Labeling	STANDARD	Label Letter
2017/05/02	SUPPL-37（补充）	Approval	Labeling	STANDARD	Label Letter	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/05/02	SUPPL-35（补充）	Approval	Labeling	STANDARD	Label Letter
2016/08/05	SUPPL-34（补充）	Approval	Labeling	STANDARD	Letter Label
2016/08/05	SUPPL-33（补充）	Approval	Labeling	STANDARD	Letter Label
2016/05/20	SUPPL-32（补充）	Approval	Manufacturing (CMC)	STANDARD
2016/03/24	SUPPL-31（补充）	Approval	Labeling	STANDARD	Label Letter
2014/09/18	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/06/25	SUPPL-29（补充）	Approval	Labeling	STANDARD	Letter Label
2014/06/25	SUPPL-28（补充）	Approval	Labeling	STANDARD	Label Letter
2014/06/25	SUPPL-27（补充）	Approval	Labeling	STANDARD	Letter Label
2013/10/09	SUPPL-26（补充）	Approval	Manufacturing (CMC)	STANDARD
2013/06/26	SUPPL-25（补充）	Approval	Manufacturing (CMC)	STANDARD
2011/06/07	SUPPL-22（补充）	Approval	Labeling	UNKNOWN	Letter
2008/04/14	SUPPL-16（补充）	Approval	Labeling	STANDARD	Letter Label
2008/02/21	SUPPL-15（补充）	Approval	Labeling	STANDARD	Letter Label
2004/09/29	SUPPL-13（补充）	Approval	Labeling	STANDARD	Label Letter
2004/01/28	SUPPL-14（补充）	Approval	Labeling	STANDARD	Letter
1998/03/09	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/12/12	SUPPL-12（补充）	Approval	Labeling	STANDARD
1997/07/17	SUPPL-11（补充）	Approval	Labeling	STANDARD
1997/03/17	SUPPL-5（补充）	Approval	Labeling
1995/12/20	SUPPL-7（补充）	Approval	Labeling	STANDARD
1995/02/21	SUPPL-9（补充）	Approval	Labeling	STANDARD
1993/04/05	SUPPL-8（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/05/21	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/06/11	SUPPL-2（补充）	Approval	Labeling
1991/04/18	SUPPL-1（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/04/10	SUPPL-3（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/08/30	ORIG-1（原始申请）	Approval	Type 3 - New Dosage Form	STANDARD