药品注册申请号:103000
申请类型:BLA (生物制品许可申请)
申请人:ALLERGAN
申请人全名:--
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 BOTOX OnabotulinumtoxinA VIAL; SINGLE-USE 50 UNITS/VIAL No None 1991/12/09 -- Prescription
002 BOTOX OnabotulinumtoxinA VIAL; SINGLE-USE 100 UNITS/VIAL No None -- Prescription
003 BOTOX OnabotulinumtoxinA VIAL; SINGLE-USE 200 UNITS/VIAL No None -- Prescription
004 BOTOX COSMETIC OnabotulinumtoxinA VIAL; SINGLE-USE 50 UNITS/VIAL No None -- Prescription
005 BOTOX COSMETIC OnabotulinumtoxinA VIAL; SINGLE-USE 100 UNITS/VIAL No None -- Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/18 SUPPL 5310 Approval Efficacy STANDARD
2019/06/20 SUPPL 5309 Approval Efficacy PRIORITY
2018/09/12 SUPPL 5308 Approval Efficacy STANDARD
2018/05/16 SUPPL 5306 Approval Labeling STANDARD
2018/05/15 SUPPL 5307 Approval Labeling STANDARD
2017/10/02 SUPPL 5303 Approval Efficacy STANDARD
2017/04/20 SUPPL 5302 Approval Labeling STANDARD Label for BOTOX
2017/04/04 SUPPL 5298 Approval Efficacy STANDARD
2017/04/04 SUPPL 5297 Approval Efficacy STANDARD
2017/04/04 SUPPL 5296 Approval Efficacy STANDARD
2016/02/04 SUPPL 5294 Approval Efficacy STANDARD
2016/01/21 SUPPL 5252 Approval Efficacy STANDARD
2015/08/11 SUPPL 5292 Approval Labeling STANDARD
2015/08/05 SUPPL 5244 Approval Labeling STANDARD
2015/04/17 SUPPL 5282 Approval Efficacy STANDARD
2014/05/07 SUPPL 5280 Approval Labeling STANDARD
2013/09/11 SUPPL 5260 Approval Efficacy STANDARD
2013/01/18 SUPPL 5251 Approval Efficacy STANDARD
2012/11/09 SUPPL 5253 Approval Labeling STANDARD
2012/07/16 SUPPL 5256 Approval Labeling STANDARD
2011/08/24 SUPPL 5232 Approval Efficacy STANDARD
2011/06/23 SUPPL 5236 Approval Supplement
2010/10/15 SUPPL 5215 Approval Efficacy STANDARD
2010/06/03 SUPPL 5219 Approval Supplement
2010/03/26 SUPPL 5129 Approval Efficacy STANDARD
2010/03/26 SUPPL 5120 Approval Labeling STANDARD
2010/03/09 SUPPL 5189 Approval Efficacy PRIORITY
2009/08/21 SUPPL 5197 Approval Supplement
2009/07/31 SUPPL 5210 Approval Labeling STANDARD
2009/07/31 SUPPL 5209 Approval Labeling STANDARD
2008/08/06 SUPPL 5184 Approval Supplement
2008/03/21 SUPPL 5171 Approval Supplement
2007/09/06 SUPPL 5165 Approval Supplement
2007/08/23 SUPPL 5160 Approval Supplement
2007/06/18 SUPPL 5159 Approval Supplement
2007/04/26 SUPPL 5156 Approval Supplement
2007/03/01 SUPPL 5151 Approval Supplement
2006/09/28 SUPPL 5148 Approval Supplement
2006/08/17 SUPPL 5144 Approval Supplement
2005/11/10 SUPPL 5122 Approval Supplement
2005/04/14 SUPPL 5101 Approval Supplement
2005/03/11 SUPPL 5097 Approval Supplement
2005/02/01 SUPPL 5092 Approval Labeling STANDARD
2004/07/19 SUPPL 5083 Approval Labeling STANDARD
2004/07/19 SUPPL 5050 Approval Efficacy STANDARD
2002/04/12 SUPPL 5000 Approval Efficacy STANDARD
2000/12/21 SUPPL 1004 Approval Efficacy UNKNOWN
1991/12/09 ORIG 1 Approval Type 1 - New Molecular Entity UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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