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FDA Drug Application 018679 by MAYNE PHARMA

Application Number018679
Application Type New Drug Application
Sponsor ApplicantMAYNE PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/30/1982N       
AP04/7/1986SC       
AP02/6/1985SC       
AP02/6/1985SC       
AP06/18/1985SC       
AP05/19/1986SC       
AP05/19/1986SC       
AP010/8/1986SC       
AP011/27/1987SC       
AP011/27/1987SC       
AP03/1/1993SC       
AP03/14/1989SL       
AP010/17/1994SC       
AP07/17/1995SC       
AP02/16/1995SC       
AP09/5/1996SC       
AP04/16/1997SC       
AP03/6/1997SL       
AP05/16/2000SCB       
AP07/7/2000SCB       
AP05/15/2002SCR       
AP05/15/2002SCB       
AP05/15/2002SCS       
AP05/15/2002SL       
AP05/15/2002SCF       
AP05/15/2002SCC       
AP07/12/2012S44205040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018679s040lbl.pdf 10/14/2015
AP09/21/2016SCM       
AP08/11/2016SCM       
AP06/13/2016SLR46330044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018679Orig1s044ltr.pdf 6/15/2016
AP06/13/2016SLR46350044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018679s044lbl.pdf 6/17/2016




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