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FDA Drug Application 202880 by PERNIX IRELAND PAIN

Application Number202880
Application Type New Drug Application
Sponsor ApplicantPERNIX IRELAND PAIN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/25/2013N37563000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf 10/25/2013
AP010/25/2013N37564000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdf 10/25/2013
AP010/25/2013N37752000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM374009.pdf 11/8/2013
AP010/25/2013N37818000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880Orig1s000SumR.pdf 11/15/2013
AP010/25/2013N38930000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 4/1/2014
AP010/25/2013N39042000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202880Orig1s000TOC.cfm 4/14/2014
AP09/22/2014SCM       
AP08/19/2014SLR40267002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202880Orig1s002ltr.pdf 8/20/2014
AP08/19/2014SLR40284002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf 8/20/2014
AP01/30/2015SCM41785003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s003ltr.pdf 2/5/2015
AP01/30/2015SCM41796003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003SumR.pdf 2/6/2015
AP01/30/2015SCM41860003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf 2/17/2015
AP06/26/2015S43264006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s006ltr.pdf 7/7/2015
AP04/20/2016S45733007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s007ltr.pdf 4/22/2016
AP09/30/2016S47253011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s011ltr.pdf 10/3/2016




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