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FDA Drug Application 204168 by FOREST LABS INC

Application Number204168
Application Type New Drug Application
Sponsor ApplicantFOREST LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/25/2013N36634000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204168Orig1s000ltr.pdf 7/29/2013
AP07/25/2013N36657000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204168s000lbl.pdf 7/30/2013
AP07/25/2013N38800000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000TOC.cfm 3/14/2014
AP07/25/2013N38801000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204168Orig1s000SumR.pdf 3/14/2014
AP05/23/2014SLR39348001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s001ltr.pdf 5/27/2014
AP05/23/2014SLR40143001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168Orig1s001lbl.pdf 8/5/2014
AP07/18/2014SLR39943002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204168Orig1s002ltr.pdf 7/23/2014
AP07/18/2014SLR39952002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204168s002lbl.pdf 7/23/2014
AP07/18/2014SLR40095002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM406944.pdf 8/1/2014
AP06/5/2015SCM       




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