Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021536
Company: NOVO NORDISK INC
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-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-Patient Package Insert | 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-Container/Carton Labels | 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-Patient Package Insert | 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 | |
| 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-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 |