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FDA Drug Application 202144 by ACTAVIS LABS FL INC

Application Number202144
Application Type Abbreviated New Drug Application
Sponsor ApplicantACTAVIS LABS FL INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/12/2014N39296000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202144Orig1s000ltr.pdf 5/13/2014
AP05/12/2014N40144000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202144Orig1s000lbl&MG.pdf 8/5/2014
AP05/12/2014N43169000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP06/30/2016SCM46447006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202144Orig1s006ltr.pdf 7/1/2016
AP06/30/2016SCM46478006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202144s006lbl.pdf 7/8/2016




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