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FDA Drug Application 021148 by NOVO NORDISK INC

Application Number021148
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
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
AP06/20/2000N9359000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-148_Norditropin.cfm 6/14/2004
AP06/20/2000N1310000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21148ltr.pdf 6/20/2000
AP06/20/2000N1311000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21148lbl.pdf 6/20/2000
AP03/30/2001SCP5070001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21148S1ltr.pdf 4/10/2001
AP08/16/2001SCP       
AP04/25/2005SCS11526004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021148s004ltr.pdf 4/28/2005
AP010/1/2004SCP10365006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s006ltr.pdf 10/5/2004
TA010/13/2004SE110549007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s007ltr.pdf 11/8/2004
AP111/1/2004SE110549007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s007ltr.pdf 11/8/2004
AP09/1/2006SLR14785013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021148s013lbl.pdf 9/1/2006
AP09/1/2006SLR14856013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021148s013ltr.pdf 9/18/2006
AP02/12/2007SLR15865015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s015lbl.pdf 2/21/2007
AP02/12/2007SLR15879015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s015ltr.pdf 2/23/2007
AP05/31/2007SE116670016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s016ltr.pdf 6/4/2007
AP05/31/2007SE116687016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s016lbl.pdf 6/4/2007
AP09/20/2007SE117970017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s017ltr.pdf 9/25/2007
AP09/20/2007SE118012017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s017lbl.pdf 9/26/2007
AP09/14/2007SCS17971018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s018ltr.pdf 9/25/2007
AP09/14/2007SCS17895018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf 9/19/2007
AP010/31/2008SE121125023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021148s023ltr.pdf 11/3/2008
AP010/31/2008SE121164023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021148s023lbl.pdf 11/7/2008
AP03/10/2009SCS22000025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021148s025ltr.pdf 3/16/2009
AP03/10/2009SCS22122025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021148s025lbl.pdf 3/26/2009
AP03/1/2010SCM24881027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf 3/2/2010
AP06/12/2015SCM       
AP05/25/2011SLR28947035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021148s035lbl.pdf 5/25/2011
AP05/25/2011SLR28963035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021148s035ltr.pdf 5/26/2011
AP010/14/2013SLR37421039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021148Orig1s039ltr.pdf 10/15/2013
AP010/14/2013SLR37432039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf 10/14/2013
AP05/15/2013SCM       
AP09/25/2014SLR40644041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021148Orig1s041ltr.pdf 9/29/2014
AP09/25/2014SLR40655041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021148s041lbl.pdf 9/30/2014
AP01/23/2015SLR41685042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s042ltr.pdf 1/26/2015
AP01/23/2015SLR41726042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s042lbl.pdf 1/29/2015
AP06/12/2015SLR43061043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s043ltr.pdf 6/15/2015
AP06/12/2015SLR43065043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf 6/15/2015
AP07/7/2015SLR43318044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s044ltr.pdf 7/10/2015
AP07/7/2015SLR43467044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s044lbl.pdf 7/23/2015
AP01/13/2016SCM       
AP06/23/2016SCM       




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