Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761219
Company: CELLTRION
Company: CELLTRION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YUFLYMA | ADALIMUMAB-AATY | 40MG/0.4ML | 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 |
|---|---|---|---|---|---|---|---|
| 05/23/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/16/2025 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s018ltr.pdf | |
| 04/07/2025 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s017ltr.pdf | |
| 05/21/2025 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s016ltr.pdf | |
| 12/23/2024 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761219Orig1s013ltr.pdf | |
| 08/16/2024 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761219Orig1s011ltr.pdf | |
| 05/21/2025 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s009ltr.pdf | |
| 12/22/2023 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf | |
| 12/22/2023 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf | |
| 12/22/2023 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf | |
| 09/21/2023 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s004ltr.pdf | |
| 09/06/2023 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s003ltr.pdf | |
| 11/30/2023 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s002ltr.pdf | |
| 10/02/2023 | SUPPL-1 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s001lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/16/2025 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s018lbl.pdf | |
| 05/21/2025 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s016lbl.pdf | |
| 05/21/2025 | SUPPL-9 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s009lbl.pdf | |
| 04/07/2025 | SUPPL-17 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s017lbl.pdf | ||
| 12/23/2024 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s013lbl.pdf | |
| 12/23/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s013lbl.pdf | |
| 08/16/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s011lbl.pdf | |
| 12/22/2023 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf | |
| 12/22/2023 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf | |
| 12/22/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf | |
| 12/22/2023 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf | |
| 12/22/2023 | SUPPL-6 | Bioequivalence | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf | |
| 11/30/2023 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf | |
| 11/30/2023 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf | |
| 10/02/2023 | SUPPL-1 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s001lbl.pdf | |
| 09/21/2023 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf | |
| 09/21/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf | |
| 09/06/2023 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf | |
| 09/06/2023 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf | |
| 05/23/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf |