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FDA Drug Application 021527 by BOEHRINGER INGELHEIM

Application Number021527
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
AP011/17/2004N10657000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21527ltr.pdf 12/2/2004
AP011/17/2004N10721000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21527lbl.pdf 12/3/2004
AP011/17/2004N15695000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021527s000TOC.cfm 1/23/2007
AP03/23/2006SLR13858003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527S003ltr.pdf 4/5/2006
AP09/5/2006SLR14813005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021527s005lbl.pdf 9/15/2006
AP09/5/2006SLR14833005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021527s005_ltr.pdf 9/15/2006
AP010/14/2008SLR21043011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021527s011ltr.pdf 10/22/2008
AP012/23/2010SLR27370016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf 12/26/2010
AP012/23/2010SLR27412016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021527s016ltr.pdf 12/28/2010
AP010/6/2011SLR30241019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021527s019ltr.pdf 10/12/2011
AP010/6/2011SLR30257019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021527s019lbl.pdf 10/12/2011
AP08/29/2012SLR33606021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021527Orig1s021ltr.pdf 8/31/2012
AP08/29/2012SLR33621021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf 8/31/2012
AP04/29/2015SCM       
AP05/9/2014SCM       
AP04/29/2016SCM       
AP010/5/2016SCM       




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