药品名称ZANTAC
申请号019090产品号001
活性成分RANITIDINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 25MG BASE/ML
治疗等效代码AP参比药物
批准日期1984/10/19申请机构IGI LABORATORIES INC
化学类型New dosage form审评分类Standard 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
019090053APLabel2009/10/06下载
019090053APLetter2009/11/12下载
019090051APLetter2009/02/19下载
019090051APLabel2009/03/27下载
019090050APLetter2006/07/21下载
019090045APLetter2002/01/07下载
019090037APReview2003/04/29下载
019090037APLetter2004/07/01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
019090053AP2009/09/04Labeling Revision
019090051AP2009/02/17Labeling Revision
019090050AP2006/07/12Labeling Revision
019090047AP2002/03/14Package Change
019090046AP2002/01/15Control Supplement
019090045AP2002/01/07Labeling Revision
019090044AP2001/05/09Labeling Revision
019090043AP1999/10/29Labeling Revision
019090042AP1999/04/02Manufacturing Change or Addition
019090041AP2001/11/06Manufacturing Change or Addition
019090040AP1999/10/22Labeling Revision
019090039AP1999/10/22Labeling Revision
019090038AP1998/01/14Control Supplement
019090037AP1999/10/29Labeling Revision
019090035AP1994/11/03Labeling Revision
019090032AP1993/04/05Labeling Revision
019090031AP1992/07/22Control Supplement
019090030AP1991/09/05Labeling Revision
019090029AP1990/12/20Manufacturing Change or Addition
019090028AP1992/05/19Package Change
019090027AP1990/11/21Labeling Revision
019090026AP1990/12/12Manufacturing Change or Addition
019090025AP1990/07/16Labeling Revision
019090024AP1991/11/25Labeling Revision
019090021AP1990/06/25Control Supplement
019090020AP1989/05/18Labeling Revision
019090019AP1989/08/08Manufacturing Change or Addition
019090018AP1990/09/26Package Change
019090017AP1990/08/13New Dosage Regimen
019090016AP1989/03/17Labeling Revision
019090015AP1988/05/20Labeling Revision
019090014AP1988/05/20Labeling Revision
019090013AP1989/03/17Labeling Revision
019090012AP1988/05/19Labeling Revision
019090011AP1987/11/24Manufacturing Change or Addition
019090009AP1987/04/09Labeling Revision
019090008AP1988/03/03Package Change
019090006AP1986/08/08Control Supplement
019090005AP1987/04/09Manufacturing Change or Addition
019090004AP1987/04/09Package Change
019090003AP1986/02/28Manufacturing Change or Addition
019090002AP1985/08/08Package Change
019090001AP1985/04/16Manufacturing Change or Addition
019090000AP1984/10/19Approval