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FDA Drug Application 022210 by FOREST LABS INC

Application Number022210
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
AP08/27/2009N23249000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022210s000lbl.pdf 8/27/2009
AP08/27/2009N23262000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022210s000ltr.pdf 9/1/2009
AP08/27/2009N23274000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf 9/2/2009
AP08/27/2009N25859000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210_zenpep_toc.cfm 6/29/2010
AP08/27/2009N25860000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022210s000sumr.pdf 6/29/2010
AP07/13/2011SCM29513005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005MedG.pdf 7/14/2011
AP07/13/2011SCM29514005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s005lbl.pdf 7/14/2011
AP06/15/2011SCM29204006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022210s006lbl.pdf 6/16/2011
AP06/15/2011SCM29227006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s006ltr.pdf 6/17/2011
AP06/10/2011SLR29150008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022210s008ltr.pdf 6/15/2011
AP04/11/2013SLR35697009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,012ltr.pdf 4/16/2013
AP04/11/2013SLR35725009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf 4/16/2013
AP09/26/2014SCM       
AP04/11/2013SLR35698012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf 4/16/2013
AP04/11/2013SLR35726012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf 4/16/2013
AP012/9/2013SCM       
AP03/25/2014SCM38921016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022210s016lbl.pdf 3/27/2014




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