药品名称VIDEX
申请号020154产品号005
活性成分DIDANOSINE市场状态停止上市
剂型或给药途径TABLET, CHEWABLE;ORAL规格150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1991/10/09申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
化学类型New molecular entity (NME)审评分类
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
48617592006/08/29U-248PDF格式
4861759*PED2007/03/01U-248PDF格式
52545392006/08/29U-248PDF格式
5254539*PED2007/03/01U-248PDF格式
56165662006/08/29U-180PDF格式
5616566*PED2007/03/01U-180PDF格式
58801062011/07/22PDF格式
5880106*PED2012/01/22PDF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
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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
020154050APLabel2006/12/04下载
020154050APLetter2006/12/28下载
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020154049APLetter2006/09/18下载
020154049APReview2007/11/19下载
020154044APLetter2004/01/22下载
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020154041APLetter2002/09/25下载
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020154041APReview2005/04/27下载
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020154037APLabel2002/04/01下载
020154036APLabel2003/04/21下载
020154035APLabel2003/04/21下载
020154033APReview2005/04/19下载
020154032APReview2005/04/19下载
020154030APReview2004/08/09下载
020154030APLetter1999/10/29下载
020154030APLabel1999/10/29下载
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020154029APLabel1999/10/29下载
020154029APReview2004/08/09下载
020154028APReview2005/01/06下载
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020154009APReview2007/08/06下载
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020154000APOther Important Information from FDA2010/08/09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
020154050AP2006/11/29Labeling Revision
020154049AP2006/08/18Labeling Revision
020154044AP2004/01/21Labeling Revision
020154042AP2003/03/04Labeling Revision
020154041AP2002/09/25Labeling Revision
020154040AP2002/09/25Labeling Revision
020154039AP2002/08/23Control Supplement
020154037AP2002/04/01Efficacy Supplement with Clinical Data to Support
020154036AP2001/11/16Labeling Revision
020154035AP2001/09/10Labeling Revision
020154034AP2001/07/27Labeling Revision
020154033AP2000/07/24Efficacy Supplement with Clinical Data to Support
020154032AP2000/07/24Labeling Revision
020154031AP2000/07/03Labeling Revision
020154030AP1999/10/28Formulation Revision
020154029AP1999/10/28New Dosage Regimen
020154028AP1999/07/01New or Modified Indication
020154027AP1998/11/25Control Supplement
020154026AP1998/11/25Control Supplement
020154025AP1998/06/23Control Supplement
020154024AP1998/01/05Control Supplement
020154023AP1998/04/23Labeling Revision
020154022AP1996/07/31Manufacturing Change or Addition
020154021AP1996/06/26Labeling Revision
020154020AP1996/07/17New or Modified Indication
020154019AP1996/03/13Control Supplement
020154018AP1995/07/14Control Supplement
020154017AP1995/06/15Labeling Revision
020154016AP1996/06/26Labeling Revision
020154015AP1995/08/21Labeling Revision
020154014AP1995/08/21Labeling Revision
020154013AP1994/02/10Labeling Revision
020154012AP1995/08/21Labeling Revision
020154011AP1996/02/27Formulation Revision
020154010AP1994/04/13Control Supplement
020154009AP1994/08/05New or Modified Indication
020154008AP1995/08/21Labeling Revision
020154007AP1994/02/10Labeling Revision
020154006AP1992/09/25New Dosage Regimen
020154004AP1993/02/04Package Change
020154001AP1992/04/01Control Supplement
020154000AP1991/10/09Approval