药品名称NAROPIN
申请号020533产品号011
活性成分ROPIVACAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径SOLUTION;INJECTION规格200MG/20ML (10MG/ML)
治疗等效代码AP参比药物
批准日期1996/09/24申请机构FRESENIUS KABI USA LLC
化学类型New molecular entity (NME)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
020533029APLabel2012/11/15下载
020533028APLabel2013/01/07下载
020533026APLetter2014/10/30下载
020533021APLabel2010/02/25下载
020533021APLetter2010/02/25下载
020533020APLabel2010/02/25下载
020533020APLetter2010/02/25下载
020533014APLabel2006/08/09下载
020533014APLetter2006/08/11下载
020533012APLetter2004/08/12下载
020533012APLabel2004/08/12下载
020533002APReview2004/06/28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
020533032AP2016/06/06Manufacturing Change or Addition
020533030AP2013/02/16Manufacturing Change or Addition
020533029AP2012/11/09Manufacturing Change or Addition
020533028AP2012/12/26Manufacturing Change or Addition
020533027AP2012/11/15Manufacturing Change or Addition
020533026AP2014/10/29Manufacturing Change or Addition
020533024AP2013/04/21Manufacturing Change or Addition
020533021AP2010/02/19Labeling Revision
020533020AP2010/02/19Labeling Revision
020533014AP2006/08/08Labeling Revision
020533012AP2004/08/11Labeling Revision
020533008AP2002/07/17Control Supplement
020533007AP2000/11/14Manufacturing Change or Addition
020533006AP2000/02/09Control Supplement
020533005AP2000/06/22Labeling Revision
020533002AP2000/11/02New Dosage Regimen
020533001AP1998/05/01Package Change
020533000AP1996/09/24Approval