Back to FDA Applications sponsored by NOVO NORDISK INC

FDA Drug Application 020741 by NOVO NORDISK INC

Application Number020741
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/1997N       
AP08/10/1999SLR       
AP03/1/1999SCE       
AP05/18/1999SCS       
AP05/18/1999SCS       
AP08/30/1999SCM       
AP012/8/1999SCM       
AP011/26/1999SCS       
AP02/25/2000SCM       
AP08/15/2000SCM17084009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.pdf 7/6/2007
AP010/27/2000SCS       
AP01/18/2002SE83563012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf 1/18/2002
AP01/18/2002SE83565012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf 1/18/2002
AP010/21/2002SE13567013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-013ltr.pdf 10/21/2002
AP010/21/2002SE13568013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf 10/21/2002
AP08/5/2002SCE       
AP010/1/2002SCS17080015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.pdf 7/6/2007
AP011/25/2002SCE17081016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S016_PRANDIN_TABS_AP.pdf 7/6/2007
AP08/27/2003SLR6580018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf 8/29/2003
AP08/27/2003SLR6588018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf 8/29/2003
AP010/15/2003SCP6817019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf 10/17/2003
AP010/15/2003SCP17083019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020741_S019_PRANDIN_TABS_AP.pdf 7/6/2007
AP02/10/2005SLR11109022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf 2/11/2005
AP02/10/2005SLR11115022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf 2/11/2005
AP06/19/2006SLR14365030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf 6/28/2006
AP06/19/2006SLR17082030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020741_S030_PRANDIN_TABS_AP.pdf 7/6/2007
AP07/14/2008SLR20207034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf 7/15/2008
AP07/14/2008SLR20209034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf 7/15/2008
AP06/10/2009SLR22756035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf 6/16/2009
AP06/10/2009SLR22778035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf 6/22/2009
AP07/29/2010SLR26076038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf 7/31/2010
AP07/29/2010SLR26100038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf 8/3/2010
AP03/1/2012SLR32026040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf 3/5/2012
AP03/1/2012SLR32043040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf 3/6/2012
AP010/30/2015SCM       




Back to FDA Applications sponsored by NOVO NORDISK INC