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FDA Drug Application 018713 by BAYER HLTHCARE

Application Number018713
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP06/17/1983N       
AP011/13/1984SCS       
AP09/11/1985SLR       
AP06/3/1987SCM16999004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018713_S004_MYCELEX TROCHE_AP.pdf 7/6/2007
AP01/27/1988SCS       
AP01/15/1988SCE       
AP09/29/1992SE1       
AP012/7/1988SCS       
AP09/15/1989SCP       
AP01/18/1990SCS       
AP012/30/1991SLR       
AP06/30/1999SCS       
AP010/7/1999SCM17000014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018713_S014_MYCELEX TROCHE_AP.pdf 7/6/2007
AP01/23/2001SCS       
AP03/26/2001SCM17001017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018713_S017_MYCELEX TROCHE_AP.pdf 7/6/2007
AP012/15/2002SLR3654019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18713slr019ltr.pdf 12/15/2002
AP012/15/2002SLR3655019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf 12/15/2002




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