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FDA Drug Application 018487 by MYLAN

Application Number018487
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
AP08/27/1981N       
AP01/9/1985SC       
AP010/13/1989SL       
AP03/1/1988SC       
AP03/1/1988SC       
AP09/19/1989SC       
AP19/19/1989SB       
AP21/31/1990SC       
AP07/5/1990SL       
AP012/27/1990SL       
AP03/18/1992SL       
AP05/6/1992SL       
AP04/13/1993SL       
AP06/15/1993SL       
AP01/7/1994SC       
AP04/29/1996SL       
AP010/6/1997SL       
AP02/5/1998SC       
AP02/25/1998SC       
AP012/7/1998SC       
AP09/25/2001SCB       
AP09/25/2001SCS       
AP02/12/2010SCM24910040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018487s040ltr.pdf 3/3/2010
AP03/8/2016SLR45407043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018487Orig1s043ltr.pdf 3/10/2016
AP03/8/2016SLR45432043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf 3/14/2016




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