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 |
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 |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-62 | Supplement |
Label (PDF)
Label (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021536Orig1s062ltr.pdf | |
| 07/01/2022 | SUPPL-60 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021536Orig1s060ltr.pdf | |
| 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 (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 | |
| 12/27/2019 | SUPPL-56 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s056ltr.pdf | |
| 01/17/2019 | SUPPL-54 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | 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 (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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 01/30/2012 | SUPPL-29 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-21 | Supplement |
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 | Supplement |
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 | Supplement |
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 |
|---|---|---|---|---|---|
| 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 | |
| 12/08/2022 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.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 | |
| 07/01/2022 | SUPPL-60 | Labeling-Container/Carton Labels | 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-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 | |
| 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-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 | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf | |
| 05/16/2007 | SUPPL-15 | Labeling-Container/Carton Labels | 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 |