Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 203313
Company: NOVO
Company: NOVO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RYZODEG 70/30 | INSULIN ASPART; INSULIN DEGLUDEC | 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
09/25/2015 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203313Orig1s000ltr.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 |
---|---|---|---|---|---|
10/06/2022 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203313Orig1s014ltr.pdf | |
11/15/2019 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203313Orig1s009, s010ltr.pdf | |
11/15/2019 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203313Orig1s009, s010ltr.pdf | |
08/09/2018 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203313s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203313Orig1s005ltr.pdf | |
06/24/2016 | SUPPL-4 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf | |
06/24/2016 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
12/16/2016 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203313Orig1s002ltr.pdf | |
03/07/2016 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/06/2022 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf | |
10/06/2022 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf | |
10/06/2022 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203313s014lbl.pdf | |
11/15/2019 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf | |
11/15/2019 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf | |
11/15/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf | |
11/15/2019 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203313s009s010lbl.pdf | |
08/09/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203313s000lbl.pdf | |
12/16/2016 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s002lbl.pdf | |
06/24/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203313s004lbl.pdf | |
09/25/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203313lbl.pdf |