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FDA Drug Application 202811 by FOREST LABS LLC

Application Number202811
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
AP08/30/2012N33615000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202811Orig1s000ltr.pdf 8/31/2012
AP08/30/2012N33619000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf 8/31/2012
AP08/30/2012N33664000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM318437.pdf 9/6/2012
AP08/30/2012N33982000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000TOC.cfm 10/4/2012
AP08/30/2012N33983000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000SumR.pdf 10/4/2012
AP012/11/2014SCM       
AP011/8/2013SCM       
AP08/8/2013SLR36768003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202811Orig1s003ltr.pdf 8/12/2013
AP08/8/2013SLR36774003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202811s003lbl.pdf 8/12/2013
AP07/9/2014SLR39827004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202811Orig1s004ltr.pdf 7/10/2014
AP07/9/2014SLR39835004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202811s004lbl.pdf 7/11/2014
AP07/1/2014SCM       
AP01/5/2015SCM       
AP04/6/2016SLR45613007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s007lbl.pdf 4/7/2016
AP04/6/2016SLR45618007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s007ltr.pdf 4/8/2016
AP05/18/2016SCM       
AP011/23/2015SLR44571009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202811Orig1s009ltr.pdf 11/24/2015
AP011/23/2015SLR44586009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf 11/25/2015
AP08/31/2016SLR46947011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s011ltr.pdf 9/2/2016
AP08/31/2016SLR46964011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf 9/2/2016




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