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FDA Drug Application 204629 by BOEHRINGER INGELHEIM

Application Number204629
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
AP08/1/2014N40121000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf 8/4/2014
AP08/1/2014N40123000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf 8/4/2014
AP08/1/2014N40453000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm 9/9/2014
AP08/1/2014N40454000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf 9/9/2014
AP06/26/2015SE843136001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf 6/30/2015
AP06/26/2015SE843180001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf 7/1/2015
AP06/26/2015SE843137002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf 6/30/2015
AP06/26/2015SE843181002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf 7/1/2015
AP06/26/2015SE843138003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf 6/30/2015
AP06/26/2015SE843182003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf 7/1/2015
AP02/5/2016SLR45130004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf 2/9/2016
AP02/5/2016SLR45387004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf 3/4/2016
AP03/18/2016SE845472005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf 3/22/2016
AP03/18/2016SE845477005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf 3/22/2016
AP012/4/2015SLR44671007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf 12/8/2015
AP012/4/2015SLR44702007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf 12/8/2015
AP01/12/2016SCM       
AP01/21/2016SCM       
AP04/15/2016SCM       
AP07/8/2016SLR46489012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf 7/12/2016
AP09/28/2016SCM       




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