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FDA Drug Application 203108 by BOEHRINGER INGELHEIM

Application Number203108
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
AP07/31/2014N40092000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203108Orig1s000ltr.pdf 8/1/2014
AP07/31/2014N40110000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203108s000lbl.pdf 8/1/2014
AP07/31/2014N40451000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000TOC.cfm 9/8/2014
AP07/31/2014N40452000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000SumR.pdf 9/8/2014
AP06/9/2016SLR46283003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203108Orig1s003ltr.pdf 6/10/2016
AP06/9/2016SLR46310003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203108s003lbl.pdf 6/13/2016




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