Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 201280 by BOEHRINGER INGELHEIM

Application Number201280
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
AP05/2/2011N28723000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201280lbl.pdf 5/6/2011
AP05/2/2011N28724000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201280s000ltr.pdf 5/6/2011
AP05/2/2011N29052000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000TOC.cfm 6/7/2011
AP05/2/2011N29054000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf 6/7/2011
AP05/2/2011N36397000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359033.pdf 6/28/2013
AP05/22/2012SE832756002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf 5/23/2012
AP05/22/2012SE832757002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280s002ltr.pdf 5/24/2012
AP05/22/2012SE839766002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201280Orig1s002.pdf 7/7/2014
AP08/13/2012SE833448003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf 8/15/2012
AP08/13/2012SE833463003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf 8/15/2012
AP08/13/2012SE833449004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf 8/15/2012
AP08/13/2012SE833464004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf 8/15/2012
AP09/28/2012SE833888005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf 10/1/2012
AP09/28/2012SE833933005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s005ltr.pdf 10/2/2012
AP06/18/2013SLR36358006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201280Orig1s006ltr.pdf 6/20/2013
AP06/18/2013SLR36384006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf 6/25/2013
AP05/22/2014SLR39344009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf 5/23/2014
AP05/22/2014SLR39380009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf 5/28/2014
AP07/20/2015SCM       
AP07/28/2015SLR43516011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf 7/29/2015
AP07/28/2015SLR43537011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf 7/30/2015
AP08/28/2015SLR43754012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf 9/1/2015
AP08/28/2015SLR43807012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf 9/4/2015




Back to FDA Applications sponsored by BOEHRINGER INGELHEIM