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FDA Drug Application 021926 by PERNIX IRELAND LTD

Application Number021926
Application Type New Drug Application
Sponsor ApplicantPERNIX IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/15/2008N19690000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s000Revisedltr.pdf 4/22/2008
AP04/15/2008N20714000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000TOC.cfm 8/29/2008
AP04/15/2008N20715000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021926s000_SumR.pdf 8/29/2008
AP04/15/2008N24196000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089804.pdf 12/4/2009
AP010/17/2008SCM21066001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021926s001ltr.pdf 10/23/2008
AP011/14/2011SLR30584002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021926s002lbl.pdf 11/14/2011
AP011/14/2011SLR30589002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s002ltr.pdf 11/16/2011
AP03/1/2012SLR32015005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021926s005ltr.pdf 3/5/2012
AP03/1/2012SLR32164005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021926s005lbl.pdf 3/20/2012
AP09/23/2011SLR30078006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021926s006ltr.pdf 9/26/2011
AP05/13/2014SCM39306010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021926s010lbl.pdf 5/15/2014
AP05/14/2015SLR42872011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf 5/21/2015
AP05/14/2015SE842873012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021926s011s012lbl.pdf 5/21/2015
AP05/14/2015SE842834012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021926Orig1s012ltr.pdf 5/19/2015
AP05/9/2016SLR45913013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021926Orig1s013ltr.pdf 5/11/2016
AP05/9/2016SLR45994013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021926s013lbl.pdf 5/11/2016




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