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FDA Drug Application 022542 by FOREST LABS INC

Application Number022542
Application Type New Drug Application
Sponsor ApplicantFOREST LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/2012N31974000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf 3/1/2012
AP03/1/2012N31976000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022542s000ltr.pdf 3/1/2012
AP03/1/2012N31981000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000MG.pdf 3/1/2012
AP03/1/2012N36746000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542_viokace_toc.cfm 8/9/2013
AP03/1/2012N36747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542Orig1s000SumR.pdf 8/9/2013
AP01/6/2014SCM       
AP07/29/2014SCM       




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