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FDA Drug Application 020857 by VIIV HLTHCARE

Application Number020857
Application Type New Drug Application
Sponsor ApplicantVIIV HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/26/1997N       
AP02/27/1998SLR       
AP07/31/1998SCM       
AP03/8/1999SLR       
AP02/26/1999SCM       
AP04/12/1999SCS       
AP01/21/2000SLR       
AP02/1/2000SCS       
AP09/29/2000SLR10952008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-857s008_Combivir.cfm 1/11/2005
AP08/9/2002SLR2550009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf 8/9/2002
AP08/9/2002SLR2551009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf 8/9/2002
AP08/9/2002SLR17940009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S009_Combivar.pdf 9/24/2007
AP08/9/2002SLR2552010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr009,010ltr.pdf 8/9/2002
AP08/9/2002SLR2553010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857slr012lbl.pdf 8/9/2002
AP08/9/2002SLR17939010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S010_Combivar.pdf 9/24/2007
AP09/13/2002SCM17938011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S011_Epivir.pdf 9/24/2007
AP010/8/2002SLR2548012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20857slr012ltr.pdf 10/8/2002
AP010/8/2002SLR2549012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20857s12lbl.pdf 10/8/2002
AP05/17/2004SLR8648014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857slr014ltr.pdf 5/26/2004
AP05/17/2004SLR8705014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857slr014_combivir_lbl.pdf 5/27/2004
AP09/29/2004SLR10342015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20857s015ltr.pdf 10/4/2004
AP09/29/2004SLR10343015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20857s015lbl.pdf 10/4/2004
AP06/27/2006SLR14383018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s018lbl.pdf 6/28/2006
AP06/27/2006SLR14410018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s018ltr.pdf 7/3/2006
AP010/25/2006SLR15243020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020857s020lbl.pdf 10/26/2006
AP010/25/2006SLR15321020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020857s020ltr.pdf 11/6/2006
AP04/23/2007SLR16292021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020857s021lbl.pdf 4/25/2007
AP04/23/2007SLR16419021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020857s021ltr.pdf 5/1/2007
AP02/2/2009SE521739023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020857s023ltr.pdf 2/4/2009
AP02/2/2009SE521769023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020857s023lbl.pdf 2/4/2009
AP010/1/2010SLR26605026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020857s026ltr.pdf 10/4/2010
AP010/1/2010SLR26633026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020857s026lbl.pdf 10/12/2010
AP011/18/2011SLR30724028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020857s028ltr.pdf 11/22/2011
AP011/18/2011SLR30860028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020857s028lbl.pdf 12/2/2011
AP09/25/2015SLR43998030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020857Orig1s030ltr.pdf 9/28/2015
AP09/25/2015SLR44030030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/20857s030lbl.pdf 9/29/2015




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