Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021810
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLOG MIX 50/50 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT 50 UNITS/ML;50 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
08/26/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021810s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810_novolog_mix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810S000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021810Orig1s015ltr.pdf
02/25/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021810Orig1s010ltr.pdf
09/04/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/09/2013 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021810Orig1s004ltr.pdf
11/21/2017 SUPPL-1 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf
11/21/2017 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf
02/25/2015 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf
03/09/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf
03/09/2013 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf
08/26/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf

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