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FDA Drug Application 205832 by BOEHRINGER INGELHEIM

Application Number205832
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/15/2014N40814000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf 10/16/2014
AP010/15/2014N40829000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205832Orig1s000ltr.pdf 10/21/2014
AP010/15/2014N41067000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000TOC.cfm 11/21/2014
AP010/15/2014N41292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000SumR.pdf 12/17/2014
AP02/4/2016SLR45125001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205832Orig1s001ltr.pdf 2/5/2016
AP02/4/2016SLR45386001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf 3/4/2016
AP06/16/2016SCM       
AP09/23/2016SCM       




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