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FDA Drug Application 017407 by BOEHRINGER INGELHEIM

Application Number017407
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/3/1974N       
AP06/8/1976SCP       
AP07/26/1976SCP       
AP010/27/1976SCF       
AP01/17/1977SCP       
AP012/10/1976SCP       
AP02/5/1981SCP       
AP09/20/1979SES       
AP011/27/1978SCP       
AP012/10/1980SCP       
AP02/26/1980SCP       
AP09/16/1980SCE       
AP09/12/1980SCP       
AP02/20/1981SCP       
AP02/20/1981SCP       
AP04/6/1981SCP       
AP08/5/1981SCP       
AP011/3/1982SCM       
AP09/8/1987SPD       
AP04/6/1984SCF       
AP03/6/1985SCS       
AP010/2/1985SLR       
AP04/11/1986SLR       
AP09/2/1987SCM       
AP03/26/1987SLR       
AP06/20/1988SLR       
AP08/2/1996SLR       
AP08/2/1996SLR       
AP011/3/1997SCS       
AP04/30/1998SCS       
AP04/13/1999SCM       
AP01/5/2010SLR24442033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s033ltr.pdf 1/6/2010
AP01/5/2010SLR24479033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s033lbl.pdf 1/8/2010
AP011/9/2009SLR24452034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017407s034ltr.pdf 1/6/2010
AP011/9/2009SLR23876034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf 11/13/2009
AP04/7/2010SLR25248036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017407s036ltr.pdf 4/9/2010
AP04/7/2010SLR25305036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017407s036lbl.pdf 4/19/2010
AP05/31/2012SLR32812037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017407s037ltr.pdf 6/5/2012
AP05/31/2012SLR32817037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017407s037lbl.pdf 6/6/2012
AP05/21/2015SCM       




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