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FDA Drug Application 020596 by VIIV HLTHCARE

Application Number020596
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/17/1995N       
AP07/31/1996SLR       
AP04/11/1997SE1       
AP011/13/1997SCM       
AP012/15/1997SLR       
AP02/3/1998SCM       
AP012/15/1997SLR       
AP03/23/1999SE818107007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S007_Epivir.pdf 9/26/2007
AP03/8/1999SLR       
AP03/8/1999SLR       
AP010/18/1999SCF18106010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020596_S010_Epivir.pdf 9/26/2007
AP010/8/1999SCM       
AP01/5/2001SLR       
AP03/6/2001SLR1786013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF 3/6/2001
AP03/6/2001SLR10912013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm 1/6/2005
AP06/19/2001SLR       
AP010/8/2002SLR1784015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf 10/8/2002
AP010/8/2002SLR1785015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf 10/8/2002
AP06/24/2002SE21779016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf 6/24/2002
AP06/24/2002SE21780016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf 6/24/2002
AP03/1/2002SLR1777017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf 3/1/2002
AP09/13/2002SCM       
AP012/24/2002SCM18105019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020596_S019_Epivir.pdf 9/26/2007
AP011/13/2003SLR6971020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf 11/25/2003
AP011/13/2003SLR7032020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf 12/2/2003
AP011/22/2004N10690021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf 12/2/2004
AP011/22/2004N10706021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf 12/3/2004
AP011/22/2004N18104021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020596_S021_Epivir.pdf 9/26/2007
AP09/29/2004SLR10336022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf 10/4/2004
AP09/29/2004SLR10339022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf 10/4/2004
AP06/13/2006SLR18103025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020596_S025_Epivir.pdf 9/26/2007
AP06/13/2006SLR14299025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf 6/14/2006
AP06/13/2006SLR14342025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf 6/20/2006
AP010/25/2006SLR15242027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s027.pdf 10/26/2006
AP010/25/2006SLR15323027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s027ltr.pdf 11/6/2006
AP011/18/2011SLR30730030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf 11/22/2011
AP011/18/2011SLR30861030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf 12/2/2011
AP03/23/2015SE842295032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf 3/26/2015
AP03/23/2015SE842531032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf 4/14/2015
AP02/19/2015SLR41879033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf 2/20/2015
AP02/19/2015SLR41906033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf 2/24/2015
AP09/30/2015SLR44085034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf 10/2/2015
AP09/30/2015SLR44160034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf 10/7/2015
AP07/20/2016SE846576035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf 7/21/2016
AP07/20/2016SE846597035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf 7/22/2016




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