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FDA Drug Application 022525 by FOREST LABS LLC

Application Number022525
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/21/2010N25770000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf 6/2/2010
AP06/21/2010N25819000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022525s000ltr.pdf 6/24/2010
AP06/21/2010N27358000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525s000_namenda_xr_toc.cfm 12/23/2010
AP06/21/2010N27359000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdf 12/23/2010
AP06/20/2013SCM       
AP011/14/2013SCM       
AP07/3/2014SE839777005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s005ltr.pdf 7/7/2014
AP07/3/2014SE839823005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf 7/9/2014
AP09/26/2014SLR40668006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf 9/30/2014
AP09/26/2014SLR40680006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s006ltr.pdf 10/1/2014
AP09/9/2014SCM       
AP05/17/2016SCM       
AP05/18/2015SCM       




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