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FDA Drug Application 018052 by BAYER HEALTHCARE LLC

Application Number018052
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP011/8/1978N       
AP011/27/1979SDS       
AP01/3/1980SCP       
AP03/27/1981SCS       
AP012/4/1986SPD       
AP010/9/1981SCS       
AP08/17/1981SCS       
AP07/24/1985SCP       
AP05/20/1986SCS       
AP09/12/1986SCM       
AP06/18/1987SCS       
AP011/30/1990SE6       
AP010/4/1988SCS       
AP09/11/1990SCS       
AP06/23/1992SCS       
AP09/22/1993SCM       
AP04/14/1992SLR       
AP05/12/1992SLR       
AP04/21/1993SCP       
AP010/8/1992SLR       
AP04/15/1993SCP       
AP04/26/1993SE1       
AP08/11/1998SCP       
AP012/9/1998SCP       
AP01/20/2000SCM       
AP09/1/2000SCS       
AP02/2/2001SCS       
AP01/16/2002SCS       
AP04/12/2010SLR25263032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018052s032ltr.pdf 4/14/2010
AP04/12/2010SLR41614032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf 1/12/2015




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