Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 206756 by BOEHRINGER INGELHEIM

Application Number206756
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/21/2015N42876000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf 5/21/2015
AP05/21/2015N42877000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s000ltr.pdf 5/21/2015
AP05/21/2015N46434000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206756Orig1s000TOC.cfm 6/27/2016
AP06/16/2015SLR43073001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s001ltr.pdf 6/18/2015
AP06/16/2015SLR43084001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756s001lbl.pdf 6/19/2015
AP03/18/2016SE845474002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf 3/22/2016
AP03/18/2016SE845478002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s002ltr.pdf 3/22/2016
AP06/9/2016SLR46287006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s006ltr.pdf 6/10/2016
AP06/9/2016SLR46311006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf 6/13/2016




Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.