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FDA Drug Application 022382 by EGALET US INC

Application Number022382
Application Type New Drug Application
Sponsor ApplicantEGALET US INC
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
AP05/14/2010N25591000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022382s000ltr.pdf 5/21/2010
AP05/14/2010N25647000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022382s000lbl.pdf 5/28/2010
AP05/14/2010N28669000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382_sprix_toc.cfm 5/3/2011
AP05/14/2010N28670000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382Orig1s000SumR.pdf 5/3/2011
AP07/2/2013SCM       
AP07/29/2013SCM       
AP04/21/2014SLR39113009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022382Orig1s009ltr.pdf 4/22/2014
AP04/21/2014SLR39117009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022382s009lbl.pdf 4/22/2014
AP05/11/2015SCM       
AP05/9/2016SLR45962012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf 5/11/2016
AP05/9/2016SLR45904012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf 5/10/2016
AP05/9/2016SLR45905013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf 5/10/2016
AP05/9/2016SLR45963013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf 5/11/2016
AP05/9/2016SLR46053013   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501657.pdf 5/18/2016
AP06/10/2016SCM       




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