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FDA Drug Application 206255 by GALDERMA LABS LP

Application Number206255
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
AP012/19/2014N41401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206255Orig1s000ltr.pdf 12/24/2014
AP012/19/2014N41547000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206255lbl.pdf 1/8/2015
AP012/19/2014N45485000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000TOC.cfm 3/23/2016
AP012/19/2014N45486000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000SumR.pdf 3/23/2016




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