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FDA Drug Application 205551 by VIIV HLTHCARE

Application Number205551
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/22/2014N40315000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf 8/26/2014
AP08/22/2014N40321000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205551Orig1s000ltr.pdf 8/27/2014
AP08/22/2014N43621000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205551Orig1s000TOC.cfm 8/11/2015
AP06/15/2015SCM       
AP08/5/2015SLR43594002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s002lbl.pdf 8/7/2015
AP08/5/2015SLR43598002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s002ltr.pdf 8/10/2015
AP09/28/2015SLR44054004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205551Orig1s004ltr.pdf 9/30/2015
AP09/28/2015SLR44153004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205551s004lbl.pdf 10/7/2015
AP09/28/2015SLR44281004   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467819.pdf 10/23/2015
AP04/21/2016SE845732005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205551Orig1s005ltr.pdf 4/22/2016
AP04/21/2016SE845783005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205551s005lbl.pdf 4/27/2016
AP04/1/2016SCM       




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