Back to FDA Applications sponsored by NOVO NORDISK INC

FDA Drug Application 019938 by NOVO NORDISK INC

Application Number019938
Application Type New Drug Application
Sponsor ApplicantNOVO NORDISK INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/25/1991N       
AP010/7/1991SCS       
AP03/13/1992SCS       
AP03/26/1993SCS       
AP03/26/1993SLR       
AP01/7/1994SLR       
AP04/26/1994SCS       
AP05/23/1994SCS       
AP05/31/1994SCS       
AP06/16/1994SCS       
AP06/23/1994SCS       
AP06/23/1994SCP       
AP01/3/1994SLR       
AP01/4/1994SLR       
AP05/22/1995SCS       
AP08/16/1995SCS       
AP01/28/1997SCS       
AP06/13/1996SCM       
AP04/10/1997SLR4311019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938a_s019.pdf 4/10/1997
AP04/16/1997SLR4312020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938ap.pdf 11/20/1997
AP06/20/1997SCP       
AP08/4/1997SCS       
AP07/24/1998SCS       
AP010/18/1999SCM       
AP03/16/2000SCP       
AP04/10/2000SCS       
AP06/15/2000SLR       
AP012/10/2001SLR       
AP03/11/2002SLR3024030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf 3/11/2002
AP03/11/2002SLR3025030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf 3/11/2002
AP01/9/2001SCS       
AP04/11/2002SCP3022032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf 4/11/2002
AP04/11/2002SCP3023032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf 4/11/2002
AP04/15/2002SCP3012033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf 4/15/2002
AP04/15/2002SCP3013033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf 4/15/2002
AP012/19/2001SCP       
AP01/10/2002SCS       
AP06/19/2002SCM       
AP011/18/2005SLR13126037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf 11/22/2005
AP011/18/2005SLR13133037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019938s037ltr.pdf 11/22/2005
AP010/21/2005S12979048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf 10/25/2005
AP06/15/2009SLR22773063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf 6/18/2009
AP06/15/2009SLR22792063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf 6/22/2009
AP07/17/2009SCS23053064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf 7/23/2009
AP07/17/2009SCS23082064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pd 7/24/2009
AP02/27/2012SLR31925066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf 2/27/2012
AP02/27/2012SLR31962066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019938s066ltr.pdf 2/29/2012
AP06/25/2010SCM25841067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP012/27/2010SLR27446068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf 1/4/2011
AP06/25/2010SLR25842069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP03/9/2013SLR35410071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s071ltr.pdf 3/12/2013
AP03/9/2013SLR35432071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf 3/12/2013
AP02/7/2013SLR35111072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf 2/8/2013
AP02/7/2013SLR35116072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s072ltr.pdf 2/8/2013
AP012/1/2015SCM       
AP01/8/2016SLR44946074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019938Orig1s074ltr.pdf 1/11/2016
AP01/8/2016SLR44962074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf 1/12/2016




Back to FDA Applications sponsored by NOVO NORDISK INC