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FDA Drug Application 202133 by EDGEMONT PHARMS LLC

Application Number202133
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
AP010/6/2011N30244000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202133s000ltr.pdf 10/12/2011
AP010/6/2011N30255000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202133s000MedG.pdf 10/12/2011
AP010/6/2011N30256000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202133s000lbl.pdf 10/12/2011
AP010/6/2011N32529000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133_fluoxetine_toc.cfm 4/24/2012
AP010/6/2011N32531000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202133Orig1s000SumR.pdf 4/24/2012
AP07/18/2014SLR39944003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202133Orig1s003ltr.pdf 7/23/2014
AP07/18/2014SLR40065003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202133s003lbl.pdf 7/30/2014




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