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FDA Drug Application 018514 by PRECISION DERMAT

Application Number018514
Application Type New Drug Application
Sponsor ApplicantPRECISION DERMAT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/31/1982N       
AP02/20/1985SCS       
AP04/25/1995SCM       
AP02/14/1996SCF       
AP02/24/1995SCM       
AP08/30/1996SCM       
AP05/22/2002SCM3442008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18514s008ltr.pdf 5/22/2002
AP012/12/2005SCS13273009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018514s009ltr.pdf 12/15/2005
AP08/5/2013SCM       
AP01/8/2014SCM       
AP010/30/2014SLR40908013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018514Orig1s013ltr.pdf 10/31/2014
AP010/30/2014SLR40935013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf 11/4/2014




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