Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021536
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVEMIR INSULIN DETEMIR RECOMBINANT 1000 UNITS/10ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None No No
LEVEMIR FLEXPEN INSULIN DETEMIR RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
LEVEMIR FLEXTOUCH INSULIN DETEMIR RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Prescription None No No
LEVEMIR INNOLET INSULIN DETEMIR RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) INJECTABLE;SUBCUTANEOUS Discontinued None No No
LEVEMIR PENFILL INSULIN DETEMIR RECOMBINANT 300 UNITS/3ML (100 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
06/16/2005 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021536ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021-536_LevemirTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-58 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s057, s058ltr.pdf
11/15/2019 SUPPL-57 Supplement

Label is not available on this site.

12/27/2019 SUPPL-56 Supplement

Label is not available on this site.

01/17/2019 SUPPL-54 Supplement

Label is not available on this site.

02/25/2015 SUPPL-51 Supplement

Label is not available on this site.

01/23/2015 SUPPL-50 Supplement

Label is not available on this site.

02/25/2014 SUPPL-48 Supplement

Label is not available on this site.

06/10/2014 SUPPL-47 Supplement

Label is not available on this site.

03/04/2014 SUPPL-46 Supplement

Label is not available on this site.

02/15/2013 SUPPL-45 Supplement

Label is not available on this site.

04/10/2013 SUPPL-44 Supplement

Label is not available on this site.

05/18/2012 SUPPL-41 Supplement

Label is not available on this site.

04/27/2012 SUPPL-39 Supplement

Label is not available on this site.

03/29/2012 SUPPL-37 Supplement

Label is not available on this site.

03/09/2013 SUPPL-35 Supplement

Label is not available on this site.

10/31/2013 SUPPL-33 Supplement

Label is not available on this site.

02/25/2015 SUPPL-31 Supplement

Label is not available on this site.

01/22/2010 SUPPL-30 Supplement

Label is not available on this site.

01/30/2012 SUPPL-29 Supplement

Label is not available on this site.

11/05/2012 SUPPL-28 Supplement

Label is not available on this site.

05/07/2009 SUPPL-24 Supplement

Label is not available on this site.

11/28/2008 SUPPL-23 Supplement

Label is not available on this site.

09/03/2008 SUPPL-21 Supplement

Label is not available on this site.

09/03/2008 SUPPL-20 Supplement

Label is not available on this site.

05/16/2007 SUPPL-15 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-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf
11/15/2019 SUPPL-58 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf
06/16/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf

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