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FDA Drug Application 022128 by VIIV HLTHCARE

Application Number022128
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
AP08/6/2007N24076000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089122.pdf 11/20/2009
AP08/6/2007N17545000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf 8/7/2007
AP08/6/2007N17564000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022128s000ltr.pdf 8/7/2007
AP08/6/2007N18183000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022128_selzentry_toc.cfm 10/5/2007
AP011/25/2008SE721297001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022128s001ltr.pdf 11/28/2008
AP011/20/2009SE524090002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf 11/23/2009
AP011/20/2009SE524160002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf 11/27/2009
AP05/27/2010SE525682004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022128s004ltr.pdf 6/3/2010
AP05/27/2010SE525686004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022128s004lbl.pdf 6/3/2010
AP010/21/2011SLR30408007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022128s007ltr.pdf 10/25/2011
AP010/21/2011SLR30411007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022128s007lbl.pdf 10/25/2011
AP08/10/2012SLR33437009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022128Orig1s009ltr.pdf 8/15/2012
AP08/10/2012SLR33538009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022128s009lbl.pdf 8/22/2012
AP02/1/2013SLR35055010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s010ltr.pdf 2/4/2013
AP02/1/2013SLR35079010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s010lbl.pdf 2/6/2013
AP02/14/2013SLR35184011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s011ltr.pdf 2/19/2013
AP02/14/2013SLR35190011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s011lbl.pdf 2/20/2013
AP03/27/2014SLR38923012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022128Orig1s012ltr.pdf 3/28/2014
AP03/27/2014SLR38947012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022128s012lbl.pdf 4/1/2014
AP04/14/2014SCM       
AP04/21/2015SLR42628015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022128Orig1s015ltr.pdf 4/22/2015
AP04/21/2015SLR42771015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf 5/11/2015




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