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FDA Drug Application 020978 by VIIV HLTHCARE

Application Number020978
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
AP012/17/1998N2066000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf 12/17/1998
AP012/17/1998N2067000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20978lbl.pdf 12/17/1998
AP012/17/1998N2068000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-977_Ziagen.cfm 12/17/1998
AP012/17/1998N7236000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094302.htm 12/12/2003
AP012/17/1998N15921000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm224556.pdf 2/28/2007
AP04/20/2000SLR       
AP012/15/2000SE87267002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20978s2medguide.pdf 12/17/2003
AP012/15/2000SE88341002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-978S-002_review.pdf 4/14/2004
AP07/27/2000SLR       
AP07/13/2001SCS       
AP01/28/2002SLR2064006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20978s6ltr.pdf 1/28/2002
AP06/4/2002SLR       
AP010/2/2002SLR2061008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr007,20978slr008ltr.pdf 10/2/2002
AP010/2/2002SLR2062008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s7,20978s8lbl.pdf 10/2/2002
AP012/24/2002SCM18088009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020978_S009_ZIAGEN.pdf 9/26/2007
AP08/14/2002SLR2057010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf 8/14/2002
AP08/14/2002SLR2058010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20977s8lbl.pdf 8/14/2002
AP07/17/2003SLR6170012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf 7/28/2003
AP07/17/2003SLR6689012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20978slr012,20977slr010_ziagen_lbl.pdf 9/25/2003
AP04/15/2004SE78364013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 4/20/2004
AP14/15/2004SO8364013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 4/20/2004
AP04/15/2004SE78467013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf 5/3/2004
AP14/15/2004SO8467013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977se7-011,20978se7-013_ziagen_lbl.pdf 5/3/2004
AP04/15/2004SE723223013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP14/15/2004SO23223013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP08/2/2004SE218087014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf 9/26/2007
AP18/2/2004SO18087014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020978_S014_ZIAGEN.pdf 9/26/2007
AP08/2/2004SE223222014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP18/2/2004SO23222014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 8/25/2009
AP08/2/2004SE29941014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 8/5/2004
AP18/2/2004SO9941014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 8/5/2004
AP08/2/2004SE29942014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf 8/5/2004
AP18/2/2004SO9942014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s012,20978s014lbl.pdf 8/5/2004
AP07/26/2004SLR9855015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s013,20978s015ltr.pdf 7/28/2004
AP07/26/2004SLR9877015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20977s013,20978s015lbl.pdf 7/28/2004
AP08/11/2006SLR14684016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020977s014,020978s016lbl.pdf 8/14/2006
AP08/11/2006SLR14734016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf 8/21/2006
AP08/11/2006SLR18086016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020978_S016_ZIAGEN.pdf 9/26/2007
AP05/7/2007SLR16473019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020977s016,020978s019lbl.pdf 5/9/2007
AP05/7/2007SLR16480019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf 5/9/2007
AP07/18/2008SE820267020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s017,020978s020lbl.pdf 7/22/2008
AP07/18/2008SE820276020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf 7/23/2008
AP012/19/2008SLR21415022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf 12/29/2008
AP012/19/2008SLR21448022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020977s019,020978s022lbl.pdf 1/2/2009
AP08/4/2010S26194024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf 8/10/2010
AP05/13/2011SLR28846026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf 5/17/2011
AP011/18/2011SLR30732027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s023,020978s027ltr.pdf 11/22/2011
AP011/18/2011SLR30751027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020977s023,020978s027lbl.pdf 11/22/2011
AP03/15/2012SLR32134028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s024,020978s028lbl.pdf 3/16/2012
AP03/15/2012SLR32147028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf 3/19/2012
AP05/18/2012SLR32728029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020977s025,020978s029lbl.pdf 5/22/2012
AP05/18/2012SLR32748029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf 5/22/2012
AP09/11/2013SLR37084030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020977Orig1s026,020978Orig1s030ltr.pdf 9/13/2013
AP09/11/2013SLR37119030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020977s026,020978s030lbl.pdf 9/17/2013
AP03/23/2015SE842267031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf 3/25/2015
AP03/23/2015SE842342031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s027,020978s031lbl.pdf 4/1/2015
AP02/19/2015SLR41881032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s028,020978s032lbl.pdf 2/20/2015
AP02/19/2015SLR41903032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf 2/24/2015
AP09/30/2015SLR44087034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf 10/2/2015
AP09/30/2015SLR44162034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020977s030,020978s034lbl.pdf 10/7/2015




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