药品名称LEVO-T
申请号021342产品号009
活性成分LEVOTHYROXINE SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
治疗等效代码AB1,AB2,AB3参比药物
批准日期2002/03/01申请机构ALARA PHARMACEUTICAL CORPORATION
化学类型New formulation or new manufacturer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
63991012020/03/30PDF格式
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
021342020APLetter2011/03/11下载
021342016APLetter2009/06/17下载
021342016APLabel2009/06/22下载
021342014APLabel2008/06/12下载
021342014APLetter2008/06/13下载
021342008APLetter2008/06/13下载
021342008APLabel2008/06/12下载
021342004APReview2005/05/13下载
021342004APLetter2004/06/24下载
021342003APLetter2004/06/24下载
021342003APReview2005/05/13下载
021342002APLetter2003/08/28下载
021342002APLabel2003/08/28下载
021342001APLetter2003/12/11下载
021342001APLabel2003/12/11下载
021342000APReview2002/06/19下载
021342000APLetter2002/03/01下载
021342000APLabel2002/03/01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
021342024AP2015/02/09Manufacturing Change or Addition
021342022AP2012/11/20Manufacturing Change or Addition
021342020AP2011/03/09Comparative Efficacy Claim
021342016AP2009/06/14Control Supplement
021342014AP2008/06/10Labeling Revision
021342008AP2008/06/10Labeling Revision
021342004AP2004/06/23Comparative Efficacy Claim
021342003AP2004/06/23Comparative Efficacy Claim
021342002AP2003/08/21Control Supplement
021342001AP2003/12/08Control Supplement
021342000AP2002/03/01Approval