Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022341
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VICTOZA | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/25/2010 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/05/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022341Orig1s039ltr.pdf | |
| 06/10/2022 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037, s038ltr.pdf | |
| 06/10/2022 | SUPPL-37 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037, s038ltr.pdf |
| 11/20/2020 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s036ltr.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s035ltr.pdf | |
| 06/17/2019 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022341Orig1s031ltr.pdf | |
| 07/26/2017 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s029ltr.pdf |
| 04/25/2017 | SUPPL-28 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s028ltr.pdf | |
| 08/25/2017 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/022341Orig1s027.pdf | |
| 09/20/2016 | SUPPL-26 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s026ltr.pdf |
| 04/22/2016 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s025ltr.pdf | |
| 07/01/2015 | SUPPL-24 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf |
| 03/09/2015 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s023ltr.pdf | |
| 02/25/2015 | SUPPL-22 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s022ltr.pdf | |
| 07/31/2014 | SUPPL-21 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf |
| 06/13/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf | |
| 04/16/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf | |
| 12/13/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf | |
| 04/06/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf | |
| 12/03/2012 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/2012 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf | |
| 04/06/2012 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf | |
| 05/18/2011 | SUPPL-4 | Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf | |
| 12/22/2010 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/05/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf | |
| 06/10/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf | |
| 06/10/2022 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf | |
| 11/20/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf | |
| 11/20/2020 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf | |
| 08/05/2020 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf | |
| 06/17/2019 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf | |
| 08/25/2017 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf | |
| 04/25/2017 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf | |
| 04/25/2017 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf | |
| 04/22/2016 | SUPPL-25 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf | |
| 03/09/2015 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf | |
| 02/25/2015 | SUPPL-22 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf | |
| 06/13/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf | |
| 04/16/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf | |
| 12/13/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf | |
| 04/06/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf | |
| 04/06/2012 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf | |
| 04/06/2012 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf | |
| 05/18/2011 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf | |
| 05/18/2011 | SUPPL-4 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf | |
| 12/22/2010 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf | |
| 01/25/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf |