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FDA Drug Application 012836 by BOEHRINGER INGELHEIM

Application Number012836
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/6/1961N       
AP012/22/1986SE1       
AP010/8/1982SCM       
AP012/22/1986SLR       
AP02/6/1987SCS       
AP02/24/1988SLR       
AP012/12/1988SCM       
AP08/30/1989SCF       
AP011/8/1988SLR       
AP02/21/1995SCM       
AP03/26/1991SLR       
AP02/18/1994SLR       
AP05/18/1994SCF       
AP07/3/1997SLR       
AP02/8/2000SCM       
AP05/24/2001SCM       
AP08/5/2004SLR9953054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12836s054ltr.pdf 8/6/2004
AP02/8/2002SCM       
AP06/20/2002SCS       
AP08/1/2005SLR12495057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/012836s057ltr.pdf 8/3/2005
AP08/1/2005SLR12506057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/012836s057lbl.pdf 8/3/2005
AP05/8/2014SCM       
AP07/29/2015SCM       




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