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FDA Drug Application 020986 by NOVO NORDISK INC

Application Number020986
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/7/2000N815000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20986ltr.pdf 6/7/2000
AP06/7/2000N816000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf 6/7/2000
AP06/7/2000N3048000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm 6/7/2000
AP01/19/2001SCS       
AP04/11/2002SCP3046002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s2ltr.pdf 4/11/2002
AP04/11/2002SCP3047002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf 4/11/2002
AP012/21/2001SE33043003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_Approv.pdf 12/21/2001
AP012/21/2001SE33044003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf 12/21/2001
AP012/21/2001SE33045003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986se3003_Novolog.cfm 12/21/2001
AP04/11/2002SCP3041004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s4ltr.pdf 4/11/2002
AP04/11/2002SCP3042004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf 4/11/2002
AP06/26/2001SCM       
AP08/31/2001SCS       
AP07/27/2001SCM       
AP011/20/2001SCM       
AP03/5/2002SCS       
AP07/29/2002SCS       
AP012/4/2002SE83039011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986se8-011ltr.pdf 12/4/2002
AP012/4/2002SE83040011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf 12/4/2002
AP011/19/2002SCS       
AP012/4/2002SCS       
AP010/8/2004SLR10413019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf 10/15/2004
AP010/8/2004SLR10419019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf 10/15/2004
AP03/19/2004SLR8007020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986slr020ltr.pdf 3/24/2004
AP03/19/2004SLR8241020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf 4/5/2004
AP04/23/2004SCP8451023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986scp023ltr.pdf 4/29/2004
AP04/23/2004SCP8488023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf 5/4/2004
AP07/30/2004SLR9928024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s024ltr.pdf 8/2/2004
AP07/30/2004SLR9933024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf 8/2/2004
AP010/21/2005S12996032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf 11/1/2005
AP09/13/2005SE512788033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020986s033ltr.pdf 9/15/2005
AP09/13/2005SE512798033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf 9/15/2005
AP01/26/2007SE815731037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf 2/2/2007
AP01/26/2007SE815778037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020986s037ltr.pdf 2/12/2007
AP010/27/2006SCM15302040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf 11/6/2006
AP010/27/2006SCM15316040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020986s040ltr.pdf 11/6/2006
AP07/14/2009SCE22975045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf 7/16/2009
AP07/14/2009SCE22987045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s045ltr.pdf 7/17/2009
AP03/14/2008SE519475047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf 3/17/2008
AP03/14/2008SE519482047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s047ltr.pdf 3/18/2008
AP09/3/2008SLR20760049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP09/3/2008SLR20761050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP011/28/2008SLR21298053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf 11/28/2008
AP05/7/2009SLR22544054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s054ltr.pdf 5/13/2009
AP07/17/2009SCS23050055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf 7/23/2009
AP07/17/2009SCS23085055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf 7/24/2009
AP011/5/2012SLR34266057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf 11/5/2012
AP011/5/2012SLR34329057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s057ltr.pdf 11/7/2012
AP06/25/2010SCM25847058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP02/25/2015SLR41925059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf 2/27/2015
AP02/25/2015SLR42000059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf 3/3/2015
AP06/25/2010SLR25848060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP010/31/2013SLR37670061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf 11/1/2013
AP010/31/2013SLR37710061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s061ltr.pdf 11/6/2013
AP010/31/2013SLR39760061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020986Orig1s061.pdf 7/7/2014
AP011/28/2012SLR34504062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s062ltr.pdf 11/29/2012
AP012/13/2012SLR34687064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf 12/18/2012
AP012/13/2012SLR34703064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s064ltr.pdf 12/19/2012
AP03/9/2013SLR35402067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s067ltr.pdf 3/12/2013
AP03/9/2013SLR35436067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf 3/12/2013
AP03/4/2014SCM       
AP02/25/2014SLR38602075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020986Orig1s075ltr.pdf 2/27/2014
AP09/4/2014SCM       
AP09/4/2014SCM       
AP01/14/2015SE841632078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf 1/15/2015
AP01/14/2015SE841638078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s078ltr.pdf 1/16/2015
AP01/23/2015SLR41684080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s080ltr.pdf 1/26/2015
AP01/23/2015SLR41724080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf 1/29/2015
AP02/25/2015SLR41926081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf 2/27/2015
AP02/25/2015SLR42001081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf 3/3/2015
AP04/17/2015SLR42569082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s082ltr.pdf 4/20/2015
AP04/17/2015SLR42640082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf 4/23/2015
AP010/7/2016SLR47337084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf 10/12/2016
AP010/7/2016SLR47351084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020986Orig1s084ltr.pdf 10/14/2016




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