药品名称BOTOX COSMETIC
申请号103000产品号005
活性成分OnabotulinumtoxinA市场状态处方药
剂型或给药途径VIAL; SINGLE-USE规格100 UNITS/VIAL
治疗等效代码参比药物
批准日期申请机构ALLERGAN
化学类型审评分类
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
1030005294APLetter2016/02/05下载
1030005292APLetter2015/08/12下载
1030005292APLabel2015/08/12下载
1030005282APLetter2015/04/21下载
1030005282APLabel2015/04/21下载
1030005280APLetter2014/05/08下载
1030005260APLetter2013/09/13下载
1030005260APLabel2013/09/17下载
1030005256APLetter2012/07/18下载
1030005253APLetter2012/11/14下载
1030005253APMedication Guide2012/11/14下载
1030005253APLabel2012/11/14下载
1030005252APLetter2016/01/22下载
1030005252APLabel2016/01/26下载
1030005251APLetter2013/01/23下载
1030005251APLabel2013/01/23下载
1030005244APLabel2015/08/07下载
1030005244APLetter2015/08/10下载
1030005236APLabel2011/07/08下载
1030005232APLabel2011/08/30下载
1030005232APLetter2011/08/30下载
1030005232APReview2015/09/23下载
1030005215APReview2013/08/09下载
1030005215APLabel2010/10/19下载
1030005215APLetter2010/10/20下载
1030005210APLetter2009/08/07下载
1030005210APLabel2009/08/07下载
1030005209APLetter2009/08/07下载
1030005209APLabel2009/08/07下载
1030005189APReview2013/10/23下载
1030005189APLabel2010/03/17下载
1030005189APLetter2010/03/18下载
1030005050APLetter2004/07/21下载
1030005050APLabel2004/09/15下载
1030005000APLetter2004/03/11下载
1030005000APLabel2004/03/11下载
1030005000APReview2004/03/11下载
1030001004APLetter2004/03/11下载
1030001004APReview2004/03/11下载
1030000000APOther Important Information from FDA2008/08/12下载
1030000000APMedication Guide2009/11/16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
1030005294AP2016/02/04Labeling Revision
1030005292AP2015/08/11Labeling Revision
1030005282AP2015/04/17Efficacy Supplement with Clinical Data to Support
1030005280AP2014/05/07Labeling Revision
1030005260AP2013/09/11Efficacy Supplement with Clinical Data to Support
1030005256AP2012/07/16Labeling Revision
1030005253AP2012/11/09Labeling Revision
1030005252AP2016/01/21Efficacy Supplement with Clinical Data to Support
1030005251AP2013/01/18Efficacy Supplement with Clinical Data to Support
1030005244AP2015/08/05Labeling Revision
1030005236AP2011/06/23Supplement
1030005232AP2011/08/24Supplement
1030005219AP2010/06/03Supplement
1030005215AP2010/10/15Supplement
1030005210AP2009/07/31Supplement
1030005209AP2009/07/31Supplement
1030005197AP2009/08/21Supplement
1030005189AP2010/03/09Supplement
1030005184AP2008/08/06Supplement
1030005171AP2008/03/21Supplement
1030005165AP2007/09/06Supplement
1030005160AP2007/08/23Supplement
1030005159AP2007/06/18Supplement
1030005156AP2007/04/26Supplement
1030005151AP2007/03/01Supplement
1030005148AP2006/09/28Supplement
1030005144AP2006/08/17Supplement
1030005122AP2005/11/10Supplement
1030005120AP2010/03/26Supplement
1030005101AP2005/04/14Supplement
1030005097AP2005/03/11Supplement
1030005050AP2004/07/19Supplement
1030005000AP2002/04/12Supplement
1030001004AP2000/12/21Supplement
1030000000AP1991/12/09Approval