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FDA Drug Application 018858 by MYLAN

Application Number018858
Application Type New Drug Application
Sponsor ApplicantMYLAN
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
AP04/20/1984N       
AP07/31/1985SC       
AP03/20/1985SC       
AP07/31/1985SC       
AP07/31/1985SC       
AP07/31/1985SC       
AP07/31/1985SC       
AP07/31/1985SC       
AP09/24/1987SC       
AP04/12/1988SL       
AP04/26/1989SL       
AP06/22/1989SL       
AP011/20/1989SL       
AP01/31/1990SC       
AP012/10/1992SL       
AP04/20/1993SL       
AP05/2/1994SC       
AP010/5/1993SLI       
AP04/18/1996SL       
AP02/5/1998SC       
AP02/25/1998SC       
AP08/22/2002SL       
AP09/26/2002SCE       
AP05/9/2016SLR45954041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf 5/11/2016
AP05/9/2016SLR46002041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf 5/12/2016
AP05/9/2016SLR46006042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf 5/12/2016
AP05/9/2016SLR45955042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf 5/11/2016
AP07/19/2016SCM       




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