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FDA Drug Application 021936 by BOEHRINGER INGELHEIM

Application Number021936
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/24/2014N40615000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021936Orig1s000ltr.pdf 9/26/2014
AP09/24/2014N40639000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021936s000lbl.pdf 9/26/2014
AP09/24/2014N43219000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000TOC.cfm 7/2/2015
AP09/24/2014N43220000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000SumR.pdf 7/2/2015
AP01/15/2016SLR44981003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s003ltr.pdf 1/20/2016
AP01/15/2016SLR45180003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s003lbl.pdf 2/17/2016
AP06/9/2016SLR46282005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s005ltr.pdf 6/10/2016
AP06/9/2016SLR46309005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s005lbl.pdf 6/13/2016




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