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FDA Drug Application 020564 by VIIV HLTHCARE

Application Number020564
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
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       
AP010/31/1997SCM       
AP012/15/1997SLR       
AP02/3/1998SCM       
AP012/15/1997SLR       
AP03/23/1999SE818111007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020564_S007_Epivir.pdf 9/26/2007
AP011/5/1998SCS       
AP03/8/1999SLR       
AP03/8/1999SLR       
AP01/5/2001SLR       
AP03/6/2001SLR1411012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20596S13LTR.PDF 3/6/2001
AP03/6/2001SLR10911012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-564s012_20-596s013_Epivir.cfm 1/6/2005
AP06/19/2001SLR       
AP010/8/2002SLR1782014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564slr014,20596slr015ltr.pdf 10/8/2002
AP010/8/2002SLR1783014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf 10/8/2002
AP06/24/2002SE21778015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s015ltrand20596s016ltr.pdf 6/24/2002
AP06/24/2002SE21781015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf 6/24/2002
AP03/1/2002SLR1776016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20564s16ltr.pdf 3/1/2002
AP09/13/2002SCM18110017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020564_S017_Epivir.pdf 9/26/2007
AP011/13/2003SLR6972019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20596slr020,20564slr019ltr.pdf 11/25/2003
AP011/13/2003SLR7035019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf 12/2/2003
AP011/22/2004N10691020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s021,20564s020ltr.pdf 12/2/2004
AP011/22/2004N10705020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf 12/3/2004
AP011/22/2004N18109020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020564_S020_Epivir.pdf 9/26/2007
AP09/29/2004SLR10337021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20596s022,20564s021ltr.pdf 10/4/2004
AP09/29/2004SLR10338021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s022,20564s021lbl.pdf 10/4/2004
AP06/13/2006SLR14300024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020596s025,020564s024lbl.pdf 6/14/2006
AP06/13/2006SLR14343024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020596s025, 020564s024LTR.pdf 6/20/2006
AP06/13/2006SLR18108024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020564_S024_Epivir.pdf 9/26/2007
AP010/25/2006SLR15241026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020564s026lbl.pdf 10/26/2006
AP010/25/2006SLR15287026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020564s026ltr.pdf 10/31/2006
AP02/1/2008SE519070028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020564s028ltr.pdf 2/7/2008
AP02/1/2008SE519133028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020564s028lbl.pdf 2/14/2008
AP011/18/2011SLR30729031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020564s031,020596s030ltr.pdf 11/22/2011
AP011/18/2011SLR30862031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020564s031,020596s030lbl.pdf 12/2/2011
AP012/18/2012SCM       
AP03/23/2015SE842294033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s033,020596Orig1s032ltr.pdf 3/26/2015
AP03/23/2015SE842530033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s033,020596s032lbl.pdf 4/14/2015
AP02/19/2015SLR41880034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s034,020596s033lbl.pdf 2/20/2015
AP02/19/2015SLR41905034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s034,020596Orig1s033ltr.pdf 2/24/2015
AP09/30/2015SLR44084035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020564Orig1s035,020596Orig1s034ltr.pdf 10/2/2015
AP09/30/2015SLR44161035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf 10/7/2015
AP07/20/2016SE846575036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020564s036,020596s035lbl.pdf 7/21/2016
AP07/20/2016SE846596036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020564Orig1s036,020596Orig1s035ltr.pdf 7/22/2016




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