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FDA Drug Application 022421 by BOEHRINGER INGELHEIM

Application Number022421
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
AP02/19/2010N24851000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421lbl.pdf 2/25/2010
AP02/19/2010N24865000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s000ltr.pdf 2/26/2010
AP02/19/2010N26271000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000TOC.cfm 8/20/2010
AP02/19/2010N26272000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf 8/20/2010
AP02/19/2010N33795000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm 9/19/2012
AP07/13/2010SLR25971001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022421s001ltr.pdf 7/15/2010
AP07/13/2010SLR25987001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022421s001lbl.pdf 7/22/2010
AP05/8/2014SLR39265003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022421Orig1s003ltr.pdf 5/9/2014
AP05/8/2014SLR39271003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022421s003lbl.pdf 5/12/2014
AP08/31/2012SE833642006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022421Orig1s006ltr.pdf 9/5/2012
AP08/31/2012SE833672006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022421s006lbl.pdf 9/6/2012
AP03/1/2013SLR35323007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022421Orig1s007ltr.pdf 3/4/2013
AP03/1/2013SLR35341007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022421s007lbl.pdf 3/5/2013
AP07/15/2013SCM       
AP08/23/2013SCM       
AP03/27/2015SLR42334010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022421Orig1s010ltr.pdf 4/1/2015
AP03/27/2015SLR42391010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022421s010lbl.pdf 4/2/2015
AP01/14/2016SLR44970013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s013ltr.pdf 1/15/2016
AP01/14/2016SLR44973013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s013lbl.pdf 1/15/2016
AP07/28/2016SLR46690014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022421Orig1s014ltr.pdf 8/1/2016
AP07/28/2016SLR46703014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022421s014lbl.pdf 8/2/2016




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