Application 211675
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 15MG | Yes | Yes |
| 002 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | Yes |
| 003 | RINVOQ | UPADACITINIB | TABLET, EXTENDED RELEASE;ORAL | 45MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-1043 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-1043 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-1043 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-1043 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2306 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2310 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2310 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2310 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2310 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
| 0074-2310 | Rinvoq | Upadacitinib | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83758 | SUPPL | 2025-10-15 |
| 83749 | SUPPL | 2025-10-14 |
| 83745 | SUPPL | 2025-10-14 |
| 83274 | SUPPL | 2025-09-03 |
| 83273 | SUPPL | 2025-09-03 |
| 82122 | SUPPL | 2025-05-01 |
| 82037 | SUPPL | 2025-04-29 |
| 82036 | SUPPL | 2025-04-29 |
| 81769 | SUPPL | 2025-03-28 |
| 81749 | SUPPL | 2025-03-27 |
| 78995 | SUPPL | 2024-07-08 |
| 78297 | SUPPL | 2024-04-29 |
| 78296 | SUPPL | 2024-04-29 |
| 78287 | SUPPL | 2024-04-29 |
| 78286 | SUPPL | 2024-04-29 |
| 76577 | SUPPL | 2023-11-15 |
| 76569 | SUPPL | 2023-11-15 |
| 74315 | SUPPL | 2023-08-03 |
| 74625 | SUPPL | 2023-06-26 |
| 74610 | SUPPL | 2023-06-23 |
| 74312 | SUPPL | 2023-05-18 |
| 73985 | SUPPL | 2023-04-13 |
| 73982 | SUPPL | 2023-04-12 |
| 72474 | SUPPL | 2022-10-26 |
| 72472 | SUPPL | 2022-10-26 |
| 72451 | SUPPL | 2022-10-24 |
| 70954 | SUPPL | 2022-05-03 |
| 70886 | SUPPL | 2022-05-02 |
| 70566 | SUPPL | 2022-03-21 |
| 70565 | SUPPL | 2022-03-21 |
| 70546 | SUPPL | 2022-03-17 |
| 69918 | SUPPL | 2022-01-19 |
| 69917 | SUPPL | 2022-01-19 |
| 69898 | SUPPL | 2022-01-18 |
| 69594 | SUPPL | 2021-12-16 |
| 69593 | SUPPL | 2021-12-16 |
| 69571 | SUPPL | 2021-12-15 |
| 69569 | SUPPL | 2021-12-15 |
| 69568 | SUPPL | 2021-12-15 |
| 69484 | SUPPL | 2021-12-07 |
| 69483 | SUPPL | 2021-12-07 |
| 69480 | SUPPL | 2021-12-06 |
| 63949 | SUPPL | 2020-07-17 |
| 63885 | SUPPL | 2020-07-13 |
| 63884 | SUPPL | 2020-07-13 |
| 59982 | ORIG | 2019-09-12 |
| 59741 | ORIG | 2019-08-19 |
| 59735 | ORIG | 2019-08-16 |
| 59734 | ORIG | 2019-08-16 |