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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2022 SUPPL-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
12/08/2022 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
12/08/2022 SUPPL-62 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
12/08/2022 SUPPL-62 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
12/08/2022 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
12/08/2022 SUPPL-62 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf
07/01/2022 SUPPL-60 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf
07/01/2022 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf
07/01/2022 SUPPL-60 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf
12/27/2019 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s056lbl.pdf
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
11/15/2019 SUPPL-57 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf
11/15/2019 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.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
01/17/2019 SUPPL-54 Labeling-Patient 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf
03/09/2013 SUPPL-35 Labeling-Patient 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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