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FDA Drug Application 203794 by DEPOMED INC

Application Number203794
Application Type New Drug Application
Sponsor ApplicantDEPOMED 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
AP010/15/2012N34116000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf 10/17/2012
AP010/15/2012N34117000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000mg.pdf 10/17/2012
AP010/15/2012N34120000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203794Orig1s000ltr.pdf 10/18/2012
AP010/15/2012N34412000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794_nucynta_toc.cfm 11/16/2012
AP010/15/2012N34413000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794Orig1s000SumR.pdf 11/16/2012
AP01/16/2014SCM       
AP011/17/2014SLR41054002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf 11/20/2014
AP011/17/2014SLR41022002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf 11/19/2014
AP011/17/2014SLR41024003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf 11/19/2014
AP011/17/2014SLR41055003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf 11/20/2014




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