Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 No No
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 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
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 N/A 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
11/15/2019 SUPPL-72 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
11/15/2019 SUPPL-71 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
12/20/2018 SUPPL-68 Supplement

Label is not available on this site.

04/17/2015 SUPPL-64 Supplement

Label is not available on this site.

02/25/2015 SUPPL-63 Supplement

Label is not available on this site.

05/08/2017 SUPPL-62 Supplement

Label is not available on this site.

09/04/2014 SUPPL-61 Supplement

Label is not available on this site.

03/09/2013 SUPPL-53 Supplement

Label is not available on this site.

12/13/2012 SUPPL-51 Supplement

Label is not available on this site.

05/07/2010 SUPPL-49 Supplement

Label is not available on this site.

02/25/2015 SUPPL-46 Supplement

Label is not available on this site.

05/07/2010 SUPPL-45 Supplement

Label is not available on this site.

05/07/2009 SUPPL-44 Supplement

Label is not available on this site.

11/28/2008 SUPPL-43 Supplement

Label is not available on this site.

09/03/2008 SUPPL-39 Supplement

Label is not available on this site.

09/03/2008 SUPPL-38 Supplement

Label is not available on this site.

07/20/2007 SUPPL-34 Supplement

Label is not available on this site.

11/14/2005 SUPPL-23 Supplement

Label is not available on this site.

11/21/2005 SUPPL-21 Supplement

Label is not available on this site.

10/08/2004 SUPPL-13 Supplement

Label is not available on this site.

12/04/2002 SUPPL-11 Supplement

Label is not available on this site.

11/19/2002 SUPPL-10 Supplement

Label is not available on this site.

11/18/2002 SUPPL-9 Supplement

Label is not available on this site.

07/29/2002 SUPPL-8 Supplement

Label is not available on this site.

03/05/2002 SUPPL-7 Supplement

Label is not available on this site.

02/25/2002 SUPPL-6 Supplement

Label is not available on this site.

02/25/2002 SUPPL-5 Supplement

Label is not available on this site.

02/25/2002 SUPPL-4 Supplement

Label is not available on this site.

06/26/2002 SUPPL-3 Supplement

Label is not available on this site.

02/25/2002 SUPPL-2 Supplement

Label is not available on this site.

05/03/2002 SUPPL-1 Supplement

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-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf
11/15/2019 SUPPL-71 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf
11/15/2019 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.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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