Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021172
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLOG MIX 70/30 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
NOVOLOG MIX 70/30 FLEXPEN INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None Yes Yes
NOVOLOG MIX 70/30 PENFILL INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
NOVOLOG MIX 70/30 PENFILL INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/01/2001 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2018 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021172s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021172Orig1s068Ltr.pdf
04/17/2015 SUPPL-64 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s064ltr.pdf
02/25/2015 SUPPL-63 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf
05/08/2017 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021172s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021172Orig1s062ltr.pdf
09/04/2014 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

03/09/2013 SUPPL-53 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021172Orig1s053ltr.pdf
12/13/2012 SUPPL-51 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021172Orig1s051ltr.pdf
05/07/2010 SUPPL-49 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf
02/25/2015 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf
05/07/2010 SUPPL-45 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf
05/07/2009 SUPPL-44 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf
11/28/2008 SUPPL-43 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-39 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-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf
07/20/2007 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021172s034ltr.pdf
11/14/2005 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s023ltr.pdf
11/21/2005 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s021ltr.pdf
10/08/2004 SUPPL-13 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-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/2002 SUPPL-9 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172scp009ltr.pdf
07/29/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/25/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/26/2002 SUPPL-3 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172s003ltr.pdf
02/25/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/03/2002 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172S001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2018 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021172s068lbl.pdf
05/08/2017 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021172s062lbl.pdf
04/17/2015 SUPPL-64 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf
02/25/2015 SUPPL-63 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf
02/25/2015 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf
03/09/2013 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf
03/09/2013 SUPPL-53 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf
12/13/2012 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf
05/07/2010 SUPPL-49 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf
05/07/2010 SUPPL-45 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf
07/20/2007 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf
07/20/2007 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf
11/21/2005 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf
11/14/2005 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf
10/08/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf
11/18/2002 SUPPL-9 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf
06/26/2002 SUPPL-3 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf
05/03/2002 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf
11/01/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf

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