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FDA Drug Application 206439 by FOREST LABS LLC

Application Number206439
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
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
AP012/23/2014N41440000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206439Orig1s000ltr.pdf 12/30/2014
AP012/23/2014N41544000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206439lbl.pdf 1/8/2015
AP012/23/2014N42817000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000TOC.cfm 5/14/2015
AP012/23/2014N42820000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000SumR.pdf 5/14/2015
AP09/1/2015SCM       
AP010/6/2015SCM       
AP07/18/2016SE846548003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206439Orig1s003ltr.pdf 7/19/2016
AP07/18/2016SE846585003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206439s003lbl.pdf 7/21/2016




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