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FDA Drug Application 021698 by BOEHRINGER INGELHEIM

Application Number021698
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/31/2004N16704000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.cfm 6/4/2007
AP08/31/2004N10111000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21698lbl.pdf 9/3/2004
AP08/31/2004N10121000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21698ltr.pdf 9/3/2004
AP03/13/2007SCF16016003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf 3/15/2007
AP012/7/2012SCM       
AP03/12/2015SLR42138018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s018ltr.pdf 3/13/2015
AP03/12/2015SLR42291018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf 3/26/2015
AP012/11/2015SLR44760019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s019ltr.pdf 12/14/2015
AP012/11/2015SLR44860019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf 12/22/2015
AP011/20/2015SLR44557020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s020Ltr.pdf 11/23/2015
AP011/20/2015SLR44596020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s020lbl.pdf 11/25/2015
AP03/21/2016SLR45475022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s022ltr.pdf 3/22/2016
AP03/21/2016SLR45529022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698s022lbl.pdf 3/29/2016
AP07/27/2016SLR46674023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf 7/28/2016
AP07/27/2016SLR46869023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf 8/23/2016
AP08/26/2016SLR46894024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s024ltr.pdf 8/29/2016
AP08/26/2016SLR46918024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Orig1s024lbl.pdf 8/30/2016




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