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FDA Drug Application 204855 by ACTAVIS LABS FL INC

Application Number204855
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
TA04/30/2015TA42738000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204855Orig1s000TAltr.pdf 5/6/2015
AP14/28/2016N42738000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204855Orig1s000TAltr.pdf 5/6/2015
TA04/30/2015TA45822000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204855Orig1s000ltr.pdf 5/2/2016
AP14/28/2016N45822000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204855Orig1s000ltr.pdf 5/2/2016
TA04/30/2015TA45839000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204855Orig1s000lbl.pdf 5/3/2016
AP14/28/2016N45839000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204855Orig1s000lbl.pdf 5/3/2016
TA04/30/2015TA46050000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501648.pdf 5/18/2016
AP14/28/2016N46050000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501648.pdf 5/18/2016




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