FDA Approval for AMJEVITA issued to AMGEN INC
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761024
Company: AMGEN INC
Company: AMGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMJEVITA | ADALIMUMAB-ATTO | 20MG/0.4ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| AMJEVITA | ADALIMUMAB-ATTO | 40MG/0.8ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/23/2016 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761024Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2024 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 07/12/2023 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s017ltr.pdf | |
| 08/14/2023 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s015ltr.pdf | |
| 03/22/2023 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s012ltr.pdf | |
| 04/06/2023 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761024Orig1s011ltr.pdf | |
| 07/28/2022 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761024Orig1s010ltr.pdf | |
| 06/13/2019 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761024Orig1s004ltr.pdf | |
| 03/15/2018 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761024Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/14/2023 | SUPPL-15 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf | |
| 07/12/2023 | SUPPL-17 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s017lbl.pdf | ||
| 04/06/2023 | SUPPL-11 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024Orig1s011lbl.pdf | |
| 03/22/2023 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s012lbl.pdf | |
| 07/28/2022 | SUPPL-10 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf | |
| 06/13/2019 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf | |
| 06/13/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf | |
| 03/15/2018 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761024s003lbl.pdf | |
| 09/23/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf |