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FDA Drug Application 020977 by VIIV HLTHCARE

Application Number020977
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
AP012/17/1998N794000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf 12/17/1998
AP012/17/1998N795000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf 12/17/1998
AP012/17/1998N2065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm 12/17/1998
AP012/17/1998N7235000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094302.htm 12/12/2003
AP012/17/1998N15920000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm224556.pdf 2/28/2007
AP04/20/2000SLR       
AP012/15/2000SE88342002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-977S-002_review.pdf 4/14/2004
AP07/27/2000SLR       
AP07/13/2001SCS       
AP01/28/2002SLR2063005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf 1/28/2002
AP06/4/2002SLR       
AP010/2/2002SLR2059007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf 10/2/2002
AP010/2/2002SLR2060007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf 10/2/2002
AP08/14/2002SLR2055008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf 8/14/2002
AP08/14/2002SLR2056008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf 8/14/2002
AP07/17/2003SLR6169010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf 7/28/2003
AP07/17/2003SLR6690010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf 9/25/2003
AP04/15/2004SE78363011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 4/20/2004
AP04/15/2004SE78466011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf 5/3/2004
AP04/15/2004SE723224011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP14/15/2004SO8363011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 4/20/2004
AP14/15/2004SO8466011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf 5/3/2004
AP14/15/2004SO23224011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP08/2/2004SE29940012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 8/5/2004
AP08/2/2004SE29943012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf 8/5/2004
AP08/2/2004SE218090012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020977_S012_Ziagen.pdf 9/26/2007
AP08/2/2004SE223225012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP18/2/2004SO9940012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 8/5/2004
AP18/2/2004SO9943012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf 8/5/2004
AP18/2/2004SO18090012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020977_S012_Ziagen.pdf 9/26/2007
AP18/2/2004SO23225012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP07/26/2004SLR9854013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf 7/28/2004
AP07/26/2004SLR9876013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf 7/28/2004
AP08/11/2006SLR14685014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf 8/14/2006
AP08/11/2006SLR14735014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf 8/21/2006
AP08/11/2006SLR18089014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020977_S014_ZIAGEN.pdf 9/26/2007
AP05/7/2007SLR16474016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf 5/9/2007
AP05/7/2007SLR16481016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf 5/9/2007
AP07/18/2008SE820268017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf 7/22/2008
AP07/18/2008SE820275017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf 7/23/2008
AP012/19/2008SE221414019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf 12/29/2008
AP012/19/2008SE221447019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf 1/2/2009
AP08/4/2010S26193020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf 8/10/2010
AP05/13/2011SLR28845022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf 5/17/2011
AP011/18/2011SLR30731023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf 11/22/2011
AP011/18/2011SLR30750023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf 11/22/2011
AP03/15/2012SLR32135024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf 3/16/2012
AP03/15/2012SLR32146024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf 3/19/2012
AP05/18/2012SLR32727025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf 5/22/2012
AP05/18/2012SLR32747025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf 5/22/2012
AP09/11/2013SLR37083026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf 9/13/2013
AP09/11/2013SLR37120026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf 9/17/2013
AP03/23/2015SE842266027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf 3/25/2015
AP03/23/2015SE842341027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf 4/1/2015
AP02/19/2015SLR41882028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf 2/20/2015
AP02/19/2015SLR41902028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf 2/24/2015
AP07/21/2015SCM       
AP09/30/2015SLR44086030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf 10/2/2015
AP09/30/2015SLR44163030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf 10/7/2015




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