药品名称MERIDIA
申请号020632产品号001
活性成分SIBUTRAMINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格5MG
治疗等效代码参比药物
批准日期1997/11/22申请机构ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
化学类型New molecular entity (NME)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
47466802007/06/11PDF格式
4746680*PED2007/12/11PDF格式
49296292007/05/29PDF格式
4929629*PED2007/11/29PDF格式
54362722012/07/25U-439PDF格式
5436272*PED2013/01/25PDF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
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
020632035APLabel2010/08/10下载
020632035APMedication Guide2010/08/10下载
020632035APLetter2010/08/10下载
020632034APLetter2010/08/10下载
020632034APMedication Guide2010/08/10下载
020632034APLabel2010/08/10下载
020632032APLetter2009/05/06下载
020632032APLabel2009/05/11下载
020632031APLetter2008/12/30下载
020632031APLabel2009/01/02下载
020632030APLetter2008/05/30下载
020632026APLabel2006/08/29下载
020632026APLetter2006/09/18下载
020632024APLetter2005/08/03下载
020632024APLabel2005/08/03下载
020632021APLabel2005/12/15下载
020632021APLetter2005/12/15下载
020632021APOther Important Information from FDA2007/07/09下载
020632020APLetter2004/12/02下载
020632019APLabel2004/12/03下载
020632019APLetter2004/12/02下载
020632017APLetter2003/09/30下载
020632017APReview2007/07/09下载
020632015APReview2008/02/19下载
020632014APReview2008/02/19下载
020632011APLetter2001/02/16下载
020632011APLabel2001/02/16下载
020632008APLetter2001/02/16下载
020632008APLabel2001/02/16下载
020632006APReview2008/02/19下载
020632004APReview2008/02/19下载
020632002APReview2008/02/19下载
020632000APReview2003/06/17下载
020632000APOther2010/09/01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
020632035AP2010/08/04Labeling Revision
020632034AP2010/08/04Labeling Revision
020632032AP2009/05/04Labeling Revision
020632031AP2008/12/24Labeling Revision
020632030AP2008/05/29Labeling Revision
020632026AP2006/08/23Labeling Revision
020632024AP2005/07/29Labeling Revision
020632021AP2005/12/08Patient Population Altered
020632020AP2004/11/24Labeling Revision
020632019AP2004/11/24Package Change
020632017AP2003/09/25Labeling Revision
020632015AP2002/10/08Manufacturing Change or Addition
020632014AP2002/08/07Package Change
020632013AP2002/04/25Manufacturing Change or Addition
020632011AP2001/02/16New Dosage Regimen
020632008AP2001/02/16Efficacy Supplement with Clinical Data to Support
020632006AP1999/11/12Labeling Revision
020632004AP1999/07/06Package Change
020632002AP1998/08/07Manufacturing Change or Addition
020632001AP1998/08/07Manufacturing Change or Addition
020632000AP1997/11/22Approval