FDA Approval for YUSIMRY issued to COHERUS BIOSCIENCES INC
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Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761216
Company: COHERUS BIOSCIENCES INC
Company: COHERUS BIOSCIENCES INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YUSIMRY | ADALIMUMAB-AQVH | 40MG | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2021 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761216Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761216Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/13/2023 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 03/31/2023 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761216Orig1s003ltr.pdf | |
| 02/27/2023 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761216Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-3 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s003lbl.pdf | ||
| 02/27/2023 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s001lbl.pdf | |
| 12/17/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf |