Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 208583
Company: NOVO
Company: NOVO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XULTOPHY 100/3.6 | INSULIN DEGLUDEC; LIRAGLUTIDE | 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/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 |
---|---|---|---|---|---|---|---|
11/21/2016 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/2023 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208583Orig1s021ltr.pdf | |
06/10/2022 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf | |
06/10/2022 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf | |
11/15/2019 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf | |
11/15/2019 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf | |
08/08/2019 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s012ltr.pdf | |
02/27/2019 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf | |
02/27/2019 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf | |
02/27/2019 | SUPPL-8 | Supplement |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf |
02/01/2019 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf | |
02/01/2019 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf | |
12/12/2017 | SUPPL-1 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208583Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/10/2023 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf | |
06/10/2022 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf | |
06/10/2022 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf | |
06/10/2022 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf | |
06/10/2022 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf | |
06/10/2022 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf | |
11/15/2019 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf | |
11/15/2019 | SUPPL-15 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf | |
11/15/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf | |
11/15/2019 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf | |
08/08/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf | |
02/27/2019 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf | |
02/27/2019 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf | |
02/01/2019 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf | |
02/01/2019 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf | |
11/21/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf |