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FDA Drug Application 007638 by BAYER HEALTHCARE LLC

Application Number007638
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
AP08/15/1950N       
AP010/18/1978SLR       
AP01/5/1979SCS       
AP012/20/1979SLR       
AP02/1/1980SCP       
AP07/3/1980SCS       
AP07/30/1980SCS       
AP06/11/1980SCM       
AP010/30/1981SLR       
AP05/7/1982SE6       
AP08/30/1982SCS       
AP01/4/1983SLR       
AP02/18/1983SCS       
AP01/30/1986SLR       
AP09/18/1984SCP       
AP01/30/1986SE6       
AP07/8/1986SCS       
AP010/20/1997SLR       
AP011/17/1998SCS       
AP05/19/2000SCS       
AP01/26/2001SCS       
AP03/6/2002SCE       
AP01/19/2006SCF13519032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf 1/30/2006
AP02/4/2008SLR19074033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf 2/7/2008
AP012/23/2015SCM44892038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/007638Orig1s038ltr.pdf 12/29/2015




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