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FDA Drug Application 022117 by FOREST LABS LLC

Application Number022117
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/13/2009N23226000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf 8/26/2009
AP08/13/2009N23233000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022117s000ltr.pdf 8/26/2009
AP08/13/2009N23523000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000TOC.cfm 10/2/2009
AP08/13/2009N23524000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000_SumR.pdf 10/2/2009
AP08/13/2009N31024000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/20/2011
AP09/3/2010SE126346003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf 8/30/2010
AP09/3/2010SE126517003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf 9/21/2010
AP09/3/2010SE126518004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf 9/21/2010
AP09/3/2010SE126345004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf 8/30/2010
AP012/1/2010SLR27167007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s007lbl.pdf 12/4/2010
AP012/1/2010SLR27247007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s007ltr.pdf 12/7/2010
AP010/11/2011SLR30289009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s009lbl.pdf 10/12/2011
AP010/11/2011SLR30298009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s009ltr.pdf 10/13/2011
AP08/9/2011SLR29735010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s010ltr.pdf 8/11/2011
AP08/9/2011SLR29739010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s010lbl.pdf 8/11/2011
AP010/21/2014SLR40862011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s011ltr.pdf 10/23/2014
AP010/21/2014SLR40870011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s011lbl.pdf 10/24/2014
AP03/21/2013SLR35495012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022117Orig1s012ltr.pdf 3/22/2013
AP03/21/2013SLR35527012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022117s012lbl.pdf 3/26/2013
AP011/8/2012SLR34337013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022117s013lbl.pdf 11/8/2012
AP011/8/2012SLR34346013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022117Orig1s013ltr.pdf 11/9/2012
AP011/18/2014SLR41028014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf 11/19/2014
AP011/18/2014SLR41057014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf 11/20/2014
AP011/18/2014SLR41058015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf 11/20/2014
AP011/18/2014SLR41029015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf 11/19/2014
AP011/18/2014SLR41030016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf 11/19/2014
AP011/18/2014SLR41059016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf 11/20/2014
AP03/12/2015SLR42142017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf 3/13/2015
AP03/12/2015SLR42175017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf 3/17/2015
AP03/12/2015SE842176018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf 3/17/2015
AP03/12/2015SE842143018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf 3/13/2015
AP03/12/2015SE842144019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf 3/13/2015
AP03/12/2015SE842177019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf 3/17/2015




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