药品名称PRONESTYL
申请号007335产品号003
活性成分PROCAINAMIDE HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构APOTHECON INC DIV BRISTOL MYERS SQUIBB
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
007335061AP1997/05/06Labeling Revision
007335060AP1995/09/12Manufacturing Change or Addition
007335059AP1992/06/08Manufacturing Change or Addition
007335058AP1991/10/03New or Modified Indication
007335057AP1989/12/22Package Change
007335056AP1989/03/30Labeling Revision
007335055AP1987/10/09Control Supplement
007335054AP1987/06/12Labeling Revision
007335053AP1989/03/30Labeling Revision
007335052AP1986/05/20Control Supplement
007335051AP1984/05/07Formulation Revision
007335050AP1983/10/12Expiration Date Change
007335049AP1985/05/29Formulation Revision
007335048AP1983/05/04Control Supplement
007335047AP1982/12/15Control Supplement
007335046AP1982/09/22Manufacturing Change or Addition
007335045AP1985/05/09Practioner Draft Labeling
007335044AP1981/01/27Package Change
007335043AP1985/05/09Practioner Draft Labeling
007335042AP1980/04/28Formulation Revision
007335041AP1979/03/06Control Supplement
007335040AP1979/04/05Labeling Revision
007335039AP1978/06/30Expiration Date Change
007335038AP1978/06/07Control Supplement
007335037AP1978/06/07Formulation Revision
007335036AP1977/10/21Control Supplement
007335035AP1977/10/21Control Supplement
007335034AP1977/09/14Control Supplement
007335032AP1977/09/14Package Change
007335030AP1978/08/10Labeling Revision
007335029AP1976/09/08Package Change
007335023AP1976/09/08Other Amendment
007335000AP1950/06/02Approval