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FDA Drug Application 206073 by BOEHRINGER INGELHEIM

Application Number206073
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
AP01/30/2015N41761000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s000ltr.pdf 2/3/2015
AP01/30/2015N41771000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s000lbl.pdf 2/3/2015
AP01/30/2015N45649000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000TOC.cfm 4/11/2016
AP01/30/2015N45650000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf 4/11/2016
AP08/28/2015SLR43756001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf 9/1/2015
AP08/28/2015SLR43806001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf 9/4/2015
AP012/4/2015SLR44666003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s003ltr.pdf 12/7/2015
AP012/4/2015SLR44704003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf 12/8/2015
AP07/8/2016SLR46485006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf 7/11/2016
AP17/8/2016SLR46485006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf 7/11/2016




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