Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 201281 by BOEHRINGER INGELHEIM

Application Number201281
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
AP01/30/2012N31627000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf 2/1/2012
AP01/30/2012N31632000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281s000ltr.pdf 2/2/2012
AP01/30/2012N36396000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359031.pdf 6/28/2013
AP01/30/2012N36603000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281_linagliptin_toc.cfm 7/26/2013
AP01/30/2012N36604000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf 7/26/2013
AP09/25/2012SLR33860002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281Orig1s002ltr.pdf 9/27/2012
AP06/18/2013SLR36359003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s003ltr.pdf 6/20/2013
AP06/18/2013SLR36385003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf 6/25/2013
AP09/5/2013SE837008004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf 9/9/2013
AP09/5/2013SE837033004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s004ltr.pdf 9/10/2013
AP012/18/2013SCM       
AP07/30/2014SE840080006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201281Orig1s006ltr.pdf 7/31/2014
AP07/30/2014SE840082006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf 7/31/2014
AP05/22/2014SLR39345007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf 5/23/2014
AP05/22/2014SLR39381007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf 5/28/2014
AP07/28/2015SLR43517008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf 7/29/2015
AP07/28/2015SLR43538008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf 7/30/2015
AP09/18/2015SCM       
AP08/28/2015SLR43755010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf 9/1/2015
AP08/28/2015SLR43783010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf 9/3/2015
AP02/11/2016SCM       
AP04/29/2016SCM       
AP010/7/2016SCM       




Back to FDA Applications sponsored by BOEHRINGER INGELHEIM