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FDA Drug Application 022320 by GALDERMA LABS LP

Application Number022320
Application Type New Drug Application
Sponsor ApplicantGALDERMA LABS LP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/8/2008N21385000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022320s000ltr.pdf 12/19/2008
AP012/8/2008N21483000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf 1/2/2009
AP012/8/2008N24503000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320_epiduo_toc.cfm 1/13/2010
AP012/8/2008N24504000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_SumR.pdf 1/13/2010
AP02/18/2011SLR27958001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf 2/24/2011
AP02/18/2011SLR27968001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s001ltr.pdf 2/24/2011
AP012/14/2011SLR31084002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf 12/20/2011
AP012/14/2011SLR31085002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s002ltr.pdf 12/20/2011
AP02/1/2013SE835060004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022320Orig1s004ltr.pdf 2/4/2013
AP02/1/2013SE835081004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf 2/6/2013
AP02/15/2013SCM       
AP07/1/2014SCM       
AP08/1/2014SCM       




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