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FDA Drug Application 021536 by NOVO NORDISK INC

Application Number021536
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
AP06/16/2005N11839000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021536ltr.pdf 6/21/2005
AP06/16/2005N11853000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf 6/21/2005
AP06/16/2005N12292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021-536_LevemirTOC.cfm 7/26/2005
AP05/16/2007SCF16624015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021536s015ltr.pdf 5/29/2007
AP05/16/2007SCF16629015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf 5/29/2007
AP05/16/2007SCF30823015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021536Orig1s015.pdf 10/28/2011
AP09/3/2008SLR20764020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP09/3/2008SLR20765021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf 9/9/2008
AP011/28/2008SLR       
AP05/7/2009SLR22546024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf 5/13/2009
AP011/5/2012SLR34268028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf 11/5/2012
AP011/5/2012SLR34327028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536Orig1s028ltr.pdf 11/7/2012
AP01/30/2012SLR31606029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s029lbl.pdf 1/30/2012
AP01/30/2012SLR31621029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s029ltr.pdf 2/1/2012
AP02/25/2015SLR41934031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf 2/27/2015
AP02/25/2015SLR41995031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf 3/3/2015
AP010/31/2013SLR37720033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s033ltr.pdf 11/7/2013
AP010/31/2013SLR37857033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536Orig1s033lbl.pdf 11/19/2013
AP010/31/2013SLR40097033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021536Orig1s033.pdf 8/1/2014
AP03/9/2013SLR35417035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s035ltr.pdf 3/12/2013
AP03/9/2013SLR35435035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf 3/12/2013
AP03/29/2012SE832316037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf 3/29/2012
AP03/29/2012SE832330037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s037ltr.pdf 4/2/2012
AP04/27/2012SE832570039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf 5/1/2012
AP04/27/2012SE832592039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s039ltr.pdf 5/2/2012
AP05/18/2012SE832729041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf 5/22/2012
AP05/18/2012SE832740041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s041ltr.pdf 5/22/2012
AP04/10/2013SLR35688044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s044ltr.pdf 4/16/2013
AP04/10/2013SLR35730044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf 4/16/2013
AP02/15/2013SCM       
AP03/4/2014SCM       
AP06/10/2014SCM       
AP02/25/2014SLR38601048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021536Orig1s048ltr.pdf 2/27/2014
AP01/23/2015SLR41687050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s050ltr.pdf 1/26/2015
AP01/23/2015SLR41843050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s050lbl.pdf 2/13/2015
AP02/25/2015SLR41935051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf 2/27/2015
AP02/25/2015SLR41996051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf 3/3/2015
AP08/11/2016SCM       




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