Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211675
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RINVOQ | UPADACITINIB | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| RINVOQ | UPADACITINIB | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| RINVOQ | UPADACITINIB | 45MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/16/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211675Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211675Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/26/2024 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211675s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211675Orig1s021, s022ltr.pdf | |
| 04/26/2024 | SUPPL-21 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211675s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211675Orig1s021, s022ltr.pdf | |
| 11/14/2023 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s019ltr.pdf | |
| 06/22/2023 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s017ltr.pdf | |
| 05/18/2023 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s015ltr.pdf | |
| 04/10/2023 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211675Orig1s012ltr.pdf | |
| 10/21/2022 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s010ltr.pdf | |
| 12/02/2021 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675orig1s008ltr.pdf | |
| 03/16/2022 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s007ltr.pdf | |
| 12/14/2021 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf | |
| 01/14/2022 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s004ltr.pdf | |
| 04/29/2022 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211675Orig1s003ltr.pdf | |
| 12/14/2021 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211675Orig1s002,s005ltr.pdf | |
| 07/10/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211675Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/26/2024 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211675s021s022lbl.pdf | |
| 04/26/2024 | SUPPL-21 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211675s021s022lbl.pdf | |
| 11/14/2023 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s019lbl.pdf | |
| 11/14/2023 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s019lbl.pdf | |
| 06/22/2023 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s017lbl.pdf | |
| 05/18/2023 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s015lbl.pdf | |
| 04/10/2023 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf | |
| 04/10/2023 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s012lbl.pdf | |
| 10/21/2022 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s010lbl.pdf | |
| 04/29/2022 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s003lbl.pdf | |
| 03/16/2022 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf | |
| 01/14/2022 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s004lbl.pdf | |
| 12/14/2021 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf | |
| 12/14/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf | |
| 12/14/2021 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s002s005lbl.pdf | |
| 12/02/2021 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf | |
| 12/02/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211675s008lbl.pdf | |
| 07/10/2020 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf | |
| 07/10/2020 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf | |
| 08/16/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf |