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FDA Drug Application 201292 by BOEHRINGER INGELHEIM

Application Number201292
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/12/2013N36538000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s000lbl.pdf 7/12/2013
AP07/12/2013N36541000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s000ltr.pdf 7/12/2013
AP07/12/2013N36785000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000TOC.cfm 8/15/2013
AP07/12/2013N36786000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s000SumR.pdf 8/15/2013
AP07/23/2013SLR36607001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s001ltr.pdf 7/26/2013
AP07/23/2013SLR36662001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s001lbl.pdf 7/30/2013
AP07/23/2013SLR37529001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201292Orig1s001.pdf 10/23/2013
AP011/21/2013SLR37886002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201292s002lbl.pdf 11/22/2013
AP011/21/2013SLR37904002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201292Orig1s002ltr.pdf 11/25/2013
AP07/31/2014SCM       
AP011/9/2015SE844446006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s006lbl.pdf 11/12/2015
AP011/9/2015SE844471006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s006ltr.pdf 11/13/2015
AP04/15/2016SE845694007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s007ltr.pdf 4/18/2016
AP04/15/2016SE845699007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s007lbl.pdf 4/19/2016
AP012/28/2015SLR44903008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201292Orig1s008ltr.pdf 12/29/2015
AP012/28/2015SLR44925008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201292s008lbl.pdf 12/31/2015
AP04/20/2016SLR45713009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s009ltr.pdf 4/22/2016
AP04/20/2016SLR45780009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s009lbl.pdf 4/27/2016
AP010/4/2016SLR47289010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201292s010lbl.pdf 10/6/2016
AP010/4/2016SLR47295010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201292Orig1s010ltr.pdf 10/6/2016




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