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FDA Drug Application 050814 by GILEAD

Application Number050814
Application Type New Drug Application
Sponsor ApplicantGILEAD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/22/2010N28082000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814s000_cayston_toc.cfm 3/4/2011
AP02/22/2010N28083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s000SumR.pdf 3/4/2011
AP02/22/2010N24866000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s000ltr.pdf 2/26/2010
AP02/22/2010N24935000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf 3/3/2010
AP08/20/2010SLR26284001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s001ltr.pdf 8/25/2010
AP08/20/2010SLR30919001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s001.pdf 12/9/2011
AP09/24/2012SLR33841007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf 9/25/2012
AP09/24/2012SLR33845007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050814Orig1s007ltr.pdf 9/26/2012
AP02/9/2015SCM       
AP07/9/2014SCM       
AP05/19/2014SCM       
AP011/10/2014SCM       
AP01/12/2015SCM       
AP012/28/2015SCM44915016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050814Orig1s016ltr.pdf 12/30/2015




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