Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 021747 by BOEHRINGER INGELHEIM

Application Number021747
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
AP010/7/2011N30249000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021747s000ltr.pdf 10/12/2011
AP010/7/2011N30286000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf 10/12/2011
AP010/7/2011N33482000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747_combivent_toc.cfm 8/16/2012
AP010/7/2011N33483000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747Orig1s000SumR.pdf 8/16/2012
AP08/29/2012SLR33605001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf 8/31/2012
AP08/29/2012SLR33616001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf 8/31/2012
AP01/9/2013SCM       
AP08/14/2014SCM       
AP06/19/2014SCM       
AP010/17/2014SLR40845005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf 10/21/2014
AP010/17/2014SLR40855005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf 10/22/2014
AP03/9/2015SCM       
AP07/9/2015SCM       
AP01/29/2016SLR45062010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf 2/1/2016
AP01/29/2016SLR45274010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf 2/25/2016
AP04/15/2016SCM       
AP06/9/2016SLR46284013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s013ltr.pdf 6/10/2016
AP06/9/2016SLR46308013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf 6/13/2016
AP06/17/2016SCM       




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.