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FDA Drug Application 022222 by FOREST LABS INC

Application Number022222
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/2012N31973000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022222s000lbl.pdf 3/1/2012
AP03/1/2012N31975000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022222s000ltr.pdf 3/1/2012
AP03/1/2012N32123000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM296221.pdf 3/15/2012
AP03/1/2012N36618000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022222_ultresa_toc.cfm 7/26/2013
AP03/1/2012N36619000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022222Orig1s000SumR.pdf 7/26/2013
AP03/20/2013SCM       
AP09/30/2014SCM40698002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022222s002lbl.pdf 10/2/2014




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