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FDA Drug Application 018708 by CUTIS HEALTH LLC

Application Number018708
Application Type New Drug Application
Sponsor ApplicantCUTIS HEALTH LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1985N23940000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191086.pdf 11/18/2009
AP012/27/1985N16048000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP02/26/1987SLR       
AP02/26/1987SCE       
AP02/26/1987SCS       
AP02/8/1991SCM       
AP08/5/1991SCP       
AP02/8/1991SCE       
AP07/11/1991SCP       
AP011/12/1993SCS       
AP02/3/1994SCP       
AP09/12/1996SCP       
AP011/14/2002SLR6196014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18708slr014ltr.pdf 7/29/2003
AP010/30/2007SLR18308017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018708s017lbl.pdf 11/7/2007
AP010/30/2007SLR18373017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018708s017ltr.pdf 11/8/2007
AP04/13/2010SLR25306018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018708s018lbl.pdf 4/20/2010
AP04/19/2013SLR35781020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf 4/23/2013
AP04/19/2013SCM35782021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018708s020s021lbl.pdf 4/23/2013




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