药品名称FLEXERIL
申请号017821产品号001
活性成分CYCLOBENZAPRINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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JANSSEN RESEARCH AND DEVELOPMENT LLC
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
017821051APLetter2013/04/16下载
017821051APLabel2013/04/16下载
017821045APLabel2003/03/05下载
017821045APLetter2004/06/04下载
017821045APReview2008/04/02下载
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
017821051AP2013/04/11Labeling Revision
017821047AP2002/11/05Manufacturing Change or Addition
017821046AP2002/10/03Manufacturing Change or Addition
017821045AP2003/02/03Efficacy Supplement with Clinical Data to Support
017821041AP1998/09/15Control Supplement
017821040AP1996/11/29Control Supplement
017821039AP1996/03/01Manufacturing Change or Addition
017821037AP1994/08/18Control Supplement
017821033AP1990/01/10Manufacturing Change or Addition
017821032AP1994/06/09Manufacturing Change or Addition
017821031AP1988/04/08Package Change
017821029AP1986/05/30Labeling Revision
017821026AP1986/01/16Labeling Revision
017821025AP1984/02/24Manufacturing Change or Addition
017821024AP1997/06/21Labeling Revision
017821023AP1983/01/04Package Change
017821021AP1982/05/13Control Supplement
017821020AP1982/04/01Manufacturing Change or Addition
017821019AP1983/06/21Package Change
017821018AP1981/05/26Package Change
017821017AP1981/05/26Manufacturing Change or Addition
017821016AP1982/06/03Labeling Revision
017821015AP1980/12/02Package Change
017821014AP1980/10/10Formulation Revision
017821013AP1980/10/10Manufacturing Change or Addition
017821012AP1980/10/10Labeling Revision
017821011AP1980/08/21Control Supplement
017821008AP1979/05/31Labeling Revision
017821007AP1979/05/03Manufacturing Change or Addition
017821004AP1978/03/02Labeling Revision
017821002AP1978/03/14Labeling Revision
017821000AP1977/08/26Approval