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FDA Drug Application 022165 by DEPOMED INC

Application Number022165
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
AP06/17/2009N       
AP07/20/2011SLR29587004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf 7/25/2011
AP09/30/2014SCM       
AP012/10/2015SCM       
AP03/10/2016SCM       
AP05/9/2016SLR45911011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf 5/11/2016
AP05/9/2016SLR45995011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf 5/11/2016




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