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FDA Drug Application 204708 by GALDERMA LABS LP

Application Number204708
Application Type New Drug Application
Sponsor ApplicantGALDERMA LABS LP
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
AP08/23/2013N36894000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204708lbl.pdf 8/27/2013
AP08/23/2013N36907000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204708Orig1s000ltr.pdf 8/27/2013
AP08/23/2013N38802000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000TOC.cfm 3/14/2014
AP08/23/2013N38803000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204708Orig1s000SumR.pdf 3/14/2014
AP09/5/2014SCM       
AP03/3/2015SCM       
AP09/23/2015SCM44304003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204708s003lbl.pdf 10/27/2015
AP07/27/2016SLR46667005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204708s005lbl.pdf 7/28/2016
AP07/27/2016SLR46670005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204708Orig1s005ltr.pdf 7/28/2016




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