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FDA Drug Application 019991 by NOVO NORDISK INC

Application Number019991
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       
AP01/28/1997SCS       
AP06/13/1996SCM       
AP04/10/1997SLR       
AP01/2/1997SCS       
AP04/16/1997SLR4308021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019991ap.pdf 4/16/1997
AP06/20/1997SCP       
AP08/4/1997SCS       
AP07/24/1998SCS       
AP05/12/1999SCS       
AP010/18/1999SCM       
AP03/16/2000SCP       
AP04/10/2000SCS       
AP06/15/2000SLR       
AP02/21/2001SCS       
AP012/10/2001SLR5339031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s31lbl.pdf 4/17/2003
AP03/11/2002SLR3028032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf 3/11/2002
AP03/11/2002SLR3029032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf 3/11/2002
AP012/13/2000SCS       
AP01/9/2001SCS       
AP04/11/2002SCP3018035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf 4/11/2002
AP04/11/2002SCP3019035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf 4/11/2002
AP04/15/2002SCP3016036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf 4/15/2002
AP04/15/2002SCP3017036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf 4/15/2002
AP012/19/2001SCP5340037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s37lbl.pdf 4/17/2003
AP01/10/2002SCS       
AP06/19/2002SCM       
AP06/15/2009SLR22775067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf 6/18/2009
AP06/15/2009SLR22794067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf 6/22/2009
AP07/17/2009SCS23051068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf 7/23/2009
AP07/17/2009SCS23084068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf 7/24/2009
AP06/25/2010SCM25845070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP012/27/2010SLR27448071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf 1/4/2011
AP06/25/2010SLR25846072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf 6/29/2010
AP03/9/2013SLR35411074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019991Orig1s074ltr.pdf 3/12/2013
AP03/9/2013SLR35434074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019991s074lbl.pdf 3/12/2013
AP01/8/2016SLR44948077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019991Orig1s077ltr.pdf 1/11/2016
AP01/8/2016SLR44963077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019991s077lbl.pdf 1/12/2016




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