药品名称UNITHROID
申请号021210产品号010
活性成分LEVOTHYROXINE SODIUM市场状态处方药
剂型或给药途径TABLET;ORAL规格0.2MG **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2000/08/21申请机构JEROME STEVENS PHARMACEUTICALS INC
化学类型Drug already marketed, but without an approved NDA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
021210006APReview2011/02/15下载
021210004APLetter2008/02/14下载
021210004APLabel2008/02/14下载
021210003APReview2005/05/13下载
021210003APLetter2004/12/22下载
021210002APReview2005/05/13下载
021210002APLetter2004/06/24下载
021210000APOther Important Information from FDA2009/05/30下载
021210000APLetter2000/08/21下载
021210000APReview2000/08/21下载
021210000APLabel2000/08/21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
021210009AP2014/09/09Manufacturing Change or Addition
021210006AP2009/09/01Manufacturing Change or Addition
021210004AP2008/02/08Formulation Revision
021210003AP2004/12/13Comparative Efficacy Claim
021210002AP2004/06/23Comparative Efficacy Claim
021210001AP2000/12/15Package Change
021210000AP2000/08/21Approval