药品名称ACTOS
申请号021073产品号002
活性成分PIOGLITAZONE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 30MG BASE
治疗等效代码AB参比药物
批准日期1999/07/15申请机构TAKEDA PHARMACEUTICALS USA INC
化学类型New molecular entity (NME)审评分类Priority 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
59655842016/06/19U-753PDF格式
61503832016/06/19U-418PDF格式
61503842016/06/19U-419PDF格式
61660422016/06/19U-414PDF格式
61660432016/06/19U-415PDF格式
61720902016/06/19U-416PDF格式
62112052016/06/19U-410PDF格式
62712432016/06/19U-411PDF格式
63036402016/08/09U-425PDF格式
63294042016/06/19U-753PDF格式
历史专利信息
46877772011/01/17PDF格式
59655842016/06/19U-417PDF格式
63294042016/06/19U-430PDF格式
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
M-352006/11/26
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
021073046APLetter2013/11/14下载
021073046APLabel2013/11/14下载
021073045APLetter2012/05/22下载
021073044APLetter2011/08/05下载
021073044APLabel2011/08/04下载
021073043APLabel2011/08/04下载
021073043APLetter2011/08/05下载
021073040APLetter2010/07/30下载
021073037APLabel2009/09/18下载
021073037APLetter2009/10/26下载
021073035APLabel2011/02/09下载
021073034APLetter2008/12/18下载
021073034APLabel2009/01/02下载
021073033APLetter2008/05/09下载
021073033APPatient Package Insert2008/06/12下载
021073031APLabel2007/08/15下载
021073031APLetter2007/08/17下载
021073030APLabel2007/09/11下载
021073030APLetter2007/09/11下载
021073029APLetter2006/10/02下载
021073028APLabel2006/11/06下载
021073028APLetter2006/11/07下载
021073027APLabel2006/09/01下载
021073027APLetter2006/09/18下载
021073026APLetter2007/03/06下载
021073026APLabel2007/03/07下载
021073024APLetter2004/07/21下载
021073024APLabel2004/07/21下载
021073024APReview2008/07/31下载
021073023APReview2008/07/31下载
021073023APLetter2004/08/05下载
021073023APLabel2004/08/05下载
021073021APLetter2003/06/22下载
021073021APLabel2003/06/22下载
021073020APLetter2003/12/04下载
021073020APLabel2003/12/08下载
021073020APReview2007/07/06下载
021073018APLetter2002/12/03下载
021073017APLetter2003/01/17下载
021073016APLetter2002/01/07下载
021073016APReview2007/11/19下载
021073015APReview2008/02/19下载
021073014APReview2007/11/19下载
021073013APReview2008/02/19下载
021073012APReview2007/07/27下载
021073010APReview2007/07/09下载
021073010APLetter2002/07/12下载
021073010APLabel2002/07/12下载
021073008APReview2007/07/27下载
021073007APReview2008/02/19下载
021073006APReview2008/02/19下载
021073005APReview2007/09/13下载
021073004APReview2008/02/19下载
021073003APReview2007/09/13下载
021073002APReview2007/09/13下载
021073001APReview2007/09/13下载
021073000APLetter1999/07/15下载
021073000APReview2000/06/30下载
021073000APLabel1999/07/15下载
021073000APMedication Guide2009/09/25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
021073047AP2013/06/27Manufacturing Change or Addition
021073046AP2013/11/12Labeling Revision
021073045AP2012/05/17Labeling Revision
021073044AP2011/08/04Labeling Revision
021073043AP2011/08/04Labeling Revision
021073040AP2010/07/29Labeling Revision
021073037AP2009/09/09Labeling Revision
021073035AP2011/02/03Labeling Revision
021073034AP2008/12/11Labeling Revision
021073033AP2008/05/07Labeling Revision
021073031AP2007/08/14Labeling Revision
021073030AP2007/09/06Labeling Revision
021073029AP2006/09/28Labeling Revision
021073028AP2006/11/04Labeling Revision
021073027AP2006/08/30Labeling Revision
021073026AP2007/02/25Efficacy Supplement with Clinical Data to Support
021073024AP2004/07/20Labeling Revision
021073023AP2004/08/03Labeling Revision
021073021AP2003/06/11Labeling Revision
021073020AP2003/11/26Efficacy Supplement with Clinical Data to Support
021073018AP2002/12/03Package Change
021073017AP2003/01/21Efficacy Supplement with Clinical Data to Support
021073016AP2002/01/07Labeling Revision
021073015AP2002/02/28Control Supplement
021073014AP2001/08/03Manufacturing Change or Addition
021073013AP2002/10/01Control Supplement
021073012AP2001/05/22Manufacturing Change or Addition
021073011AP2001/07/02Labeling Revision
021073010AP2002/07/12Efficacy Supplement with Clinical Data to Support
021073009AP2001/07/06Manufacturing Change or Addition
021073008AP2001/07/06Manufacturing Change or Addition
021073007AP2001/04/25Manufacturing Change or Addition
021073006AP2000/11/03Manufacturing Change or Addition
021073005AP2000/07/26Manufacturing Change or Addition
021073004AP2000/10/25Control Supplement
021073003AP2000/04/11Manufacturing Change or Addition
021073002AP2000/02/25Control Supplement
021073001AP2000/02/25Package Change
021073000AP1999/07/15Approval