Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 203314
Company: NOVO
Company: NOVO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRESIBA | INSULIN DEGLUDEC | 300 UNITS/3ML (100 UNITS/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
TRESIBA | INSULIN DEGLUDEC | 600 UNITS/3ML (200 UNITS/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
TRESIBA | INSULIN DEGLUDEC | 1000 UNITS/10ML (100 UNITS/ML) | SOLUTION;SUBCUTANEOUS | Prescription | 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 |
---|---|---|---|---|---|---|---|
09/25/2015 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203314Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203313and203314Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/01/2022 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf | |
07/01/2022 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf | |
11/15/2019 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203314Orig1s015, s016ltr.pdf | |
11/15/2019 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203314Orig1s015, s016ltr.pdf | |
11/21/2018 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s010ltr.pdf | |
08/09/2018 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s009ltr.pdf | |
03/26/2018 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/203314Orig1s008.pdf | |
06/24/2016 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
12/16/2016 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203314s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203314Orig1s003ltr.pdf | |
07/08/2016 | SUPPL-2 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/01/2022 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf | |
07/01/2022 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf | |
07/01/2022 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf | |
07/01/2022 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf | |
11/15/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf | |
11/15/2019 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf | |
11/15/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf | |
11/21/2018 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s010lbl.pdf | |
08/09/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s009lbl.pdf | |
03/26/2018 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s008lbl.pdf | |
12/16/2016 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203314s003lbl.pdf | |
09/25/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203314lbl.pdf |