Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020986
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLOG INSULIN ASPART RECOMBINANT 1000 UNITS/10ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
NOVOLOG FLEXPEN INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
NOVOLOG FLEXTOUCH INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None Yes No
NOVOLOG INNOLET INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
NOVOLOG PENFILL INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/07/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20986ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
11/15/2019 SUPPL-90 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
12/20/2018 SUPPL-87 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020986s087lbl.pdf
10/07/2016 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020986Orig1s084ltr.pdf
04/17/2015 SUPPL-82 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s082ltr.pdf
02/25/2015 SUPPL-81 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf
01/23/2015 SUPPL-80 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s080ltr.pdf
03/16/2017 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020986Orig1s079Lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020986Orig1s079Ltredt.pdf
01/14/2015 SUPPL-78 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s078ltr.pdf
09/04/2014 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

02/25/2014 SUPPL-75 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020986Orig1s075ltr.pdf
03/04/2014 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

03/09/2013 SUPPL-67 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s067ltr.pdf
12/13/2012 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s064ltr.pdf
11/28/2012 SUPPL-62 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s062ltr.pdf
10/31/2013 SUPPL-61 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020986Orig1s061.pdf
06/25/2010 SUPPL-60 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf
02/25/2015 SUPPL-59 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf
06/25/2010 SUPPL-58 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf
11/05/2012 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s057ltr.pdf
07/17/2009 SUPPL-55 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf
05/07/2009 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s054ltr.pdf
11/28/2008 SUPPL-53 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf
09/03/2008 SUPPL-50 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf
09/03/2008 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf
03/14/2008 SUPPL-47 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s047ltr.pdf
07/14/2009 SUPPL-45 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s045ltr.pdf
10/27/2006 SUPPL-40 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020986s040ltr.pdf
01/26/2007 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020986s037ltr.pdf
09/13/2005 SUPPL-33 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020986s033ltr.pdf
10/21/2005 SUPPL-32 Efficacy-New Route Of Administration Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf
07/30/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s024ltr.pdf
04/23/2004 SUPPL-23 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986scp023ltr.pdf
03/19/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986slr020ltr.pdf
10/08/2004 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf
12/04/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986se8-011ltr.pdf
07/29/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/27/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/31/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/11/2002 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s4ltr.pdf
12/21/2001 SUPPL-3 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986se3003_Novolog.cfm
04/11/2002 SUPPL-2 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020986Orig1s002.pdf
01/19/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf
11/15/2019 SUPPL-90 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf
11/15/2019 SUPPL-90 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf
12/20/2018 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020986s087lbl.pdf
03/16/2017 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020986Orig1s079Lbledt.pdf
10/07/2016 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf
04/17/2015 SUPPL-82 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf
02/25/2015 SUPPL-81 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf
02/25/2015 SUPPL-59 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf
01/23/2015 SUPPL-80 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf
01/14/2015 SUPPL-78 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf
10/31/2013 SUPPL-61 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf
03/09/2013 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf
03/09/2013 SUPPL-67 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf
12/13/2012 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf
11/05/2012 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf
07/17/2009 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
07/17/2009 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
07/14/2009 SUPPL-45 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf
07/14/2009 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf
03/14/2008 SUPPL-47 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf
01/26/2007 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf
10/27/2006 SUPPL-40 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf
10/21/2005 SUPPL-32 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf
09/13/2005 SUPPL-33 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf
10/08/2004 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf
07/30/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf
04/23/2004 SUPPL-23 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf
03/19/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf
12/04/2002 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf
04/11/2002 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf
04/11/2002 SUPPL-2 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf
12/21/2001 SUPPL-3 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf
06/07/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf

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