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FDA Drug Application 022497 by EDGEMONT PHARMS LLC

Application Number022497
Application Type New Drug Application
Sponsor ApplicantEDGEMONT PHARMS LLC
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
AP011/10/2011N30620000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022497s000lbl.pdf 11/16/2011
AP011/10/2011N30639000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280358.pdf 11/17/2011
AP011/10/2011N30651000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022497s000ltr.pdf 11/17/2011
AP011/10/2011N33076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497_forfivo_xl_toc.cfm 7/6/2012
AP011/10/2011N33077000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022497Orig1s000SumR.pdf 7/6/2012
AP07/17/2014SLR39901002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022497Orig1s002ltr.pdf 7/21/2014
AP07/17/2014SLR39911002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022497s002lbl.pdf 7/22/2014
AP08/30/2016SLR46942003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022497Orig1s003ltr.pdf 9/2/2016
AP08/30/2016SLR46956003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022497s003lbl.pdf 9/2/2016




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