药品名称LAZANDA
申请号022569产品号003
活性成分FENTANYL CITRATE市场状态处方药
剂型或给药途径SPRAY, METERED;NASAL规格EQ 0.3MG BASE
治疗等效代码参比药物
批准日期2015/12/21申请机构DEPOMED 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
022569022APLetter2015/12/22下载
022569020APLabel2015/01/09下载
022569020APLetter2014/12/31下载
022569019APLetter2014/12/31下载
022569019APLabel2015/01/08下载
022569017APLabel2013/11/19下载
022569017APLetter2013/11/13下载
022569015APLetter2013/11/13下载
022569015APLabel2013/11/19下载
022569013APLetter2014/12/31下载
022569013APLabel2015/01/08下载
022569012APLetter2013/11/13下载
022569012APLabel2013/11/19下载
022569007APLetter2012/06/07下载
022569007APLabel2012/06/11下载
022569005APLabel2011/12/28下载
022569005APLetter2012/01/03下载
022569002APLetter2011/11/14下载
022569000APReview2012/04/16下载
022569000APSummary Review2012/04/16下载
022569000APLetter2011/07/06下载
022569000APLabel2011/07/06下载
022569000APOther2011/07/08下载
022569000APMedication Guide2011/07/15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
022569022AP2015/12/21Manufacturing Change or Addition
022569021AP2014/09/30Manufacturing Change or Addition
022569020AP2014/12/24Supplement
022569019AP2014/12/24Labeling Revision
022569018AP2014/04/07Manufacturing Change or Addition
022569017AP2013/11/07Package Change
022569016AP2015/08/11Manufacturing Change or Addition
022569015AP2013/11/07Efficacy Supplement with Clinical Data to Support
022569013AP2014/12/24Labeling Revision
022569012AP2013/11/07Manufacturing Change or Addition
022569007AP2012/06/05Labeling Revision
022569005AP2011/12/28Labeling Revision
022569002AP2011/11/04Labeling Revision
022569000AP2011/06/30Approval