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FDA Drug Application 202080 by EGALET US INC

Application Number202080
Application Type New Drug Application
Sponsor ApplicantEGALET US INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/17/2011N29289000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf 6/27/2011
AP06/17/2011N29296000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202080s000ltr.pdf 6/28/2011
AP06/17/2011N31732000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202080_oxecta_toc.cfm 2/10/2012
AP06/3/2013SLR36196001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf 6/3/2013
AP06/3/2013SLR36202001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202080Orig1s001ltr.pdf 6/4/2013
AP01/16/2014SLR38316002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202080Origs002ltr.pdf 1/17/2014
AP01/16/2014SLR38333002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf 1/17/2014
AP01/26/2015SLR41694003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202080Orig1s003ltr.pdf 1/27/2015
AP01/26/2015SLR41846003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf 2/13/2015
AP03/7/2016SCM       




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