PRONESTYL-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	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1950/06/02	Approved Prior to Jan 1, 1982	Discontinued
002	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	CAPSULE;ORAL	375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
005	PRONESTYL	PROCAINAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	500MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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
2009/03/13	SUPPL-31（补充）	Approval	Efficacy
1997/05/06	SUPPL-61（补充）	Approval	Labeling	STANDARD
1995/09/12	SUPPL-60（补充）	Approval	Manufacturing (CMC)	PRIORITY
1992/06/08	SUPPL-59（补充）	Approval	Manufacturing (CMC)	PRIORITY
1991/10/03	SUPPL-58（补充）	Approval	Efficacy
1989/12/22	SUPPL-57（补充）	Approval	Manufacturing (CMC)	PRIORITY
1989/03/30	SUPPL-56（补充）	Approval	Labeling
1989/03/30	SUPPL-53（补充）	Approval	Labeling
1987/10/09	SUPPL-55（补充）	Approval	Manufacturing (CMC)	PRIORITY
1987/06/12	SUPPL-54（补充）	Approval	Labeling
1986/05/20	SUPPL-52（补充）	Approval	Manufacturing (CMC)	PRIORITY
1985/05/29	SUPPL-49（补充）	Approval	Manufacturing (CMC)	PRIORITY
1985/05/09	SUPPL-45（补充）	Approval	Labeling
1985/05/09	SUPPL-43（补充）	Approval	Labeling
1984/05/07	SUPPL-51（补充）	Approval	Manufacturing (CMC)	PRIORITY
1983/10/12	SUPPL-50（补充）	Approval	Manufacturing (CMC)	PRIORITY
1983/05/04	SUPPL-48（补充）	Approval	Manufacturing (CMC)	PRIORITY
1982/12/15	SUPPL-47（补充）	Approval	Manufacturing (CMC)	PRIORITY
1982/09/22	SUPPL-46（补充）	Approval	Manufacturing (CMC)	PRIORITY
1981/01/27	SUPPL-44（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/04/28	SUPPL-42（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/04/05	SUPPL-40（补充）	Approval	Labeling
1979/03/06	SUPPL-41（补充）	Approval	Manufacturing (CMC)	PRIORITY
1978/08/10	SUPPL-30（补充）	Approval	Labeling
1978/06/30	SUPPL-39（补充）	Approval	Manufacturing (CMC)	PRIORITY
1978/06/07	SUPPL-38（补充）	Approval	Manufacturing (CMC)	PRIORITY
1978/06/07	SUPPL-37（补充）	Approval	Manufacturing (CMC)	PRIORITY
1978/02/15	SUPPL-33（补充）	Approval	Labeling
1977/10/21	SUPPL-36（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/10/21	SUPPL-35（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/09/14	SUPPL-34（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/09/14	SUPPL-32（补充）	Approval	Manufacturing (CMC)	PRIORITY
1976/09/08	SUPPL-29（补充）	Approval	Manufacturing (CMC)	PRIORITY
1976/09/08	SUPPL-23（补充）	Approval	REMS	PRIORITY
1950/06/02	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	PRIORITY