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FDA Drug Application 050808 by MEDICIS

Application Number050808
Application Type New Drug Application
Sponsor ApplicantMEDICIS
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
AP05/8/2006N14103000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050808lbl.pdf 5/16/2006
AP05/8/2006N14111000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050808s000ltr.pdf 5/16/2006
AP05/8/2006N16861000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050808s000TOC.cfm 6/29/2007
AP07/23/2009SCS23092007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s007lbl.pdf 7/30/2009
AP07/23/2009SCS23104007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s007ltr.pdf 7/31/2009
AP012/30/2009SLR24434011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050808s011ltr.pdf 1/5/2010
AP012/30/2009SLR24493011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050808s011lbl.pdf 1/12/2010
AP08/7/2010SLR27292013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050808s013lbl.pdf 12/16/2010
AP03/18/2011SLR28352014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s014ltr.pdf 3/25/2011
AP03/18/2011SLR28521014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050808s014lbl.pdf 3/18/2011
AP03/18/2011SLR32227014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050808Orig1s014.pdf 3/27/2012
AP04/20/2011SLR28592015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050808s015ltr.pdf 4/21/2011
AP02/3/2016SCM       
AP04/17/2013SCM       
AP07/15/2014SCM       
AP010/21/2013SLR37497023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050808s023lbl.pdf 10/21/2013
AP010/21/2013SLR37499023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050808Orig1s023ltr.pdf 10/22/2013




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