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FDA Drug Application 021205 by VIIV HLTHCARE

Application Number021205
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
AP011/14/2000N8095000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205_Trizinir.cfm 3/28/2004
AP011/14/2000N9585000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Prntlbl.pdf 6/28/2004
AP011/14/2000N9586000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-205.pdf_Trizinir_Approv.pdf 6/28/2004
AP011/14/2000N22661000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089807.pdf 5/29/2009
AP07/13/2001SCS       
AP02/5/2002SE84110002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s2ltr.pdf 2/5/2002
AP02/5/2002SE811362002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s002_Trizivir.cfm 4/8/2005
AP06/4/2002SLR4109003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s003lbl.pdf 6/4/2002
AP06/4/2002SLR7757003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf 3/1/2004
AP06/4/2002SLR11212003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s003_Trizivir.cfm 3/8/2005
AP06/4/2002SLR7758004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205s3,s4ltr.pdf 3/1/2004
AP07/24/2002SCM17169005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021205_S005_TRIZIVIR_AP.pdf 7/9/2007
AP08/13/2002SLR4107006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf 8/13/2002
AP08/13/2002SLR4108006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s6lbl.pdf 8/13/2002
AP08/13/2002SLR11211006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-205s006_Trizivir.cfm 3/8/2005
AP010/8/2002SLR4105007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr007ltr.pdf 10/8/2002
AP010/8/2002SLR4106007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21205s7lbl.pdf 10/8/2002
AP010/31/2003SCS17168009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S009_TRIZIVIR_AP.pdf 7/9/2007
AP011/26/2003SCM17167010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021205_S010_TRIZIVIR_AP.pdf 7/9/2007
AP05/13/2005SE711622011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021205s011ltr.pdf 5/17/2005
AP05/13/2005SE711650011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021205s011lbl.pdf 5/17/2005
AP05/13/2005SE717170011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021205_S011_TRIZIVIR_AP.pdf 7/9/2007
AP05/10/2006SCM17166012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S012_TRIZIVIR_AP.pdf 7/9/2007
AP08/11/2006SLR14686014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021205s014lbl.pdf 8/14/2006
AP08/11/2006SLR14727014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021205s014LTR.pdf 8/18/2006
AP08/11/2006SLR17165014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S014_TRIZIVIR_AP.pdf 7/9/2007
AP05/7/2007SLR16475018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021205s018lbl.pdf 5/9/2007
AP05/7/2007SLR16479018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021205s018ltr.pdf 5/9/2007
AP03/9/2009SLR21986021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021205s021ltr.pdf 3/11/2009
AP03/9/2009SLR22170021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021205s021lbl.pdf 4/3/2009
AP03/31/2011SLR28436023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s023lbl.pdf 4/1/2011
AP03/31/2011SLR28441023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s023ltr.pdf 4/4/2011
AP08/4/2010S26195024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf 8/10/2010
AP05/13/2011SLR28847028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf 5/17/2011
AP011/18/2011SLR30739029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021205s029ltr.pdf 11/22/2011
AP011/18/2011SLR30772029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021205s029lbl.pdf 11/25/2011
AP03/12/2012SLR32092030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s030lbl.pdf 3/12/2012
AP03/12/2012SLR32096030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s030ltr.pdf 3/13/2012
AP05/18/2012SLR32725031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021205s031lbl.pdf 5/22/2012
AP05/18/2012SLR32746031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021205s031ltr.pdf 5/22/2012
AP09/30/2015SLR44091034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021205Orig1s034ltr.pdf 10/2/2015
AP09/30/2015SLR44159034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021205s034lbl.pdf 10/7/2015




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