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FDA Drug Application 021162 by BOEHRINGER INGELHEIM

Application Number021162
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/17/2000N1365000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21162ltr.pdf 11/17/2000
AP011/17/2000N1366000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf 11/17/2000
AP011/17/2000N7880000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-162_Micards.cfm 3/11/2004
AP011/17/2000N31210000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP04/19/2004SCM8421005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21162scm005ltr.pdf 4/29/2004
AP09/2/2005SLR12747008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf 9/8/2005
AP09/2/2005SLR12750008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021162s008ltr.pdf 9/8/2005
AP02/27/2007SLR15965016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021162s016ltr.pdf 3/6/2007
AP08/11/2009SLR23393019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf 9/17/2009
AP08/11/2009SLR24140019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf 11/25/2009
AP08/11/2009SLR23394020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf 9/17/2009
AP08/11/2009SLR24141020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf 11/25/2009
AP05/12/2011SLR28732029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf 5/6/2011
AP05/12/2011SLR28987029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf 5/27/2011
AP01/18/2012SLR31461030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s030ltr.pdf 1/23/2012
AP01/18/2012SLR31467030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf 1/23/2012
AP05/12/2011SLR28733031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf 5/6/2011
AP05/12/2011SLR28988031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf 5/27/2011
AP01/12/2016SLR44964032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021162Orig1s032ltr.pdf 1/14/2016
AP01/12/2016SLR45016032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf 1/25/2016
AP01/19/2012SLR31439034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s034ltr.pdf 1/23/2012
AP01/19/2012SLR31449034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf 1/23/2012
AP010/24/2012SLR34176035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162Orig1s035ltr.pdf 10/26/2012
AP010/24/2012SLR34328035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf 11/7/2012
AP012/12/2014SLR41246037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021162Orig1s037ltr.pdf 12/15/2014
AP012/12/2014SLR41268037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf 12/16/2014




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