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FDA Drug Application 020918 by NOVO NORDISK

Application Number020918
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/1998N588000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20918_ltr.pdf 6/22/1998
AP06/22/1998N589000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf 6/22/1998
AP06/22/1998N11862000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020918s000_GlucagenTOC.cfm 6/23/2005
AP05/30/2000SLR       
AP08/18/2000SLR       
AP07/11/2002SLR2135003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20918slr003ltr.pdf 7/11/2002
AP07/11/2002SLR17320003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020918_S003_GLUCAGEN.pdf 7/20/2007
AP04/1/2002SCS       
AP08/5/2002SCS       
AP03/1/2004SLR7790008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918slr008ltr.pdf 3/2/2004
AP03/1/2004SLR8202008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918slr008_glucagen_lbl.pdf 4/5/2004
AP03/1/2004SLR17321008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020918_S008_GLUCAGEN.pdf 7/20/2007
AP012/23/2004SCP10820012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918s012ltr.pdf 12/29/2004
AP012/23/2004SCP10837012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf 12/29/2004
AP011/14/2005SLR13114017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020918s017ltr.pdf 11/18/2005
AP011/14/2005SLR13120017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020918s017lbl.pdf 11/18/2005
AP012/15/2010SLR27299030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020918s030ltr.pdf 12/21/2010
AP012/15/2010SLR27351030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020918s030lbl.pdf 12/22/2010
AP012/29/2011SLR31361034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf 1/6/2012
AP012/29/2011SLR31393034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020918s034ltr.pdf 1/17/2012
AP01/16/2013SCM       
AP04/26/2013SCM       
AP04/26/2013SLR35889040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020918Orig1s040ltr.pdf 4/30/2013
AP03/14/2014SLR38814042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020918Orig1s042ltr.pdf 3/19/2014
AP012/10/2015SLR44768043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020918Orig1s043ltr.pdf 12/15/2015
AP012/10/2015SLR44778043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf 12/15/2015
AP010/8/2015SCM       
AP02/11/2016SCM       




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