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FDA Drug Application 019965 by NOVO NORDISK INC

Application Number019965
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       
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       
AP04/10/1997SLR       
AP04/16/1997SLR4309017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019965ap.pdf 4/16/1997
AP08/4/1997SCS       
AP01/9/2001SCS       
AP01/31/2001SCS       
AP01/10/2002SCS       
AP07/25/2003SLR6498024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19965slr024_novolin_lbl.pdf 8/15/2003
AP07/25/2003SLR6513024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19965slr024ltr.pdf 8/15/2003




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