Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
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 Yes Yes
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 Type 1 - New Molecular Entity STANDARD 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
01/17/2019 SUPPL-54 Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s054ltr.pdf
02/25/2015 SUPPL-51 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021536Orig1s051.pdf
01/23/2015 SUPPL-50 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s050ltr.pdf
02/25/2014 SUPPL-48 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021536Orig1s048ltr.pdf
06/10/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/04/2014 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s044ltr.pdf
05/18/2012 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s041ltr.pdf
04/27/2012 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s039ltr.pdf
03/29/2012 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s037ltr.pdf
03/09/2013 SUPPL-35 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s035ltr.pdf
10/31/2013 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021536Orig1s033.pdf
02/25/2015 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021536Orig1s031.pdf
01/22/2010 SUPPL-30 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/30/2012 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s029ltr.pdf
11/05/2012 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536Orig1s028ltr.pdf
05/07/2009 SUPPL-24 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-23 Labeling

Label is not available on this site.

09/03/2008 SUPPL-21 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-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf
05/16/2007 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021536s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021536Orig1s015.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2019 SUPPL-54 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf
01/17/2019 SUPPL-54 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf
01/17/2019 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf
02/25/2015 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf
02/25/2015 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf
01/23/2015 SUPPL-50 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s050lbl.pdf
10/31/2013 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536Orig1s033lbl.pdf
04/10/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf
03/09/2013 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf
03/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf
11/05/2012 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf
05/18/2012 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf
04/27/2012 SUPPL-39 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf
03/29/2012 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf
01/30/2012 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s029lbl.pdf
05/16/2007 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf
05/16/2007 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf
06/16/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf

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