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FDA Drug Application 050786 by FOREST LABS LLC

Application Number050786
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/28/2006N15031000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050786s000LTR.pdf 10/2/2006
AP09/28/2006N15375000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050786s000_PyleraTOC.cfm 11/22/2006
AP05/24/2007SCP16591001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050786s001ltr.pdf 5/29/2007
AP05/24/2007SCP16636001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf 5/29/2007
AP01/19/2011SLR27585003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050786s003ltr.pdf 1/24/2011
AP01/23/2013SLR34972007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050786s007lbl.pdf 1/24/2013
AP01/23/2013SLR34977007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050786Orig1s007ltr.pdf 1/25/2013
AP08/5/2013SCM       
AP08/14/2013SCM       
AP05/28/2014SCM       
AP02/5/2014SCM       
AP02/26/2016SCM       




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