Application 202806
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | TAFINLAR | DABRAFENIB MESYLATE | CAPSULE;ORAL | EQ 75MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0681 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0682 | Tafinlar | dabrafenib | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85589 | SUPPL | 2026-03-30 |
| 85568 | SUPPL | 2026-03-30 |
| 81913 | SUPPL | 2025-04-09 |
| 81838 | SUPPL | 2025-04-08 |
| 81669 | SUPPL | 2025-03-21 |
| 81668 | SUPPL | 2025-03-21 |
| 81520 | SUPPL | 2025-03-11 |
| 81514 | SUPPL | 2025-03-11 |
| 81071 | SUPPL | 2025-02-06 |
| 80970 | SUPPL | 2025-02-05 |
| 79094 | SUPPL | 2024-07-15 |
| 79055 | SUPPL | 2024-07-12 |
| 78022 | SUPPL | 2024-04-01 |
| 78012 | SUPPL | 2024-04-01 |
| 77644 | SUPPL | 2024-02-28 |
| 77638 | SUPPL | 2024-02-28 |
| 75348 | SUPPL | 2023-09-01 |
| 75339 | SUPPL | 2023-09-01 |
| 74400 | SUPPL | 2023-05-30 |
| 74393 | SUPPL | 2023-05-30 |
| 73794 | SUPPL | 2023-03-17 |
| 73779 | SUPPL | 2023-03-16 |
| 71446 | SUPPL | 2022-06-24 |
| 71432 | SUPPL | 2022-06-23 |
| 71430 | SUPPL | 2022-06-23 |
| 71198 | SUPPL | 2022-06-01 |
| 71171 | SUPPL | 2022-05-31 |
| 70110 | SUPPL | 2022-02-08 |
| 70109 | SUPPL | 2022-02-08 |
| 70037 | SUPPL | 2022-02-01 |
| 70036 | SUPPL | 2022-02-01 |
| 70020 | SUPPL | 2022-02-01 |
| 69489 | SUPPL | 2021-12-07 |
| 69488 | SUPPL | 2021-12-07 |
| 67464 | SUPPL | 2021-05-12 |
| 67463 | SUPPL | 2021-05-12 |
| 67451 | SUPPL | 2021-05-11 |
| 62577 | SUPPL | 2020-04-15 |
| 62576 | SUPPL | 2020-04-15 |
| 62525 | SUPPL | 2020-04-10 |
| 60457 | SUPPL | 2019-10-09 |
| 60267 | SUPPL | 2019-10-07 |
| 60266 | SUPPL | 2019-10-07 |
| 59365 | SUPPL | 2019-07-17 |
| 59362 | SUPPL | 2019-07-17 |
| 58717 | SUPPL | 2019-05-15 |
| 54044 | SUPPL | 2018-05-08 |
| 54017 | SUPPL | 2018-05-04 |
| 53990 | SUPPL | 2018-05-03 |
| 53873 | SUPPL | 2018-04-30 |
| 53786 | SUPPL | 2018-04-23 |
| 53744 | SUPPL | 2018-04-20 |
| 48829 | SUPPL | 2017-06-26 |
| 48808 | SUPPL | 2017-06-22 |
| 48758 | SUPPL | 2017-06-19 |
| 19380 | SUPPL | 2016-06-21 |
| 10113 | SUPPL | 2015-11-23 |
| 19379 | SUPPL | 2015-11-20 |
| 32308 | SUPPL | 2014-01-14 |
| 19378 | SUPPL | 2014-01-10 |
| 10112 | SUPPL | 2013-12-31 |
| 40222 | SUPPL | 2013-12-30 |
| 43413 | ORIG | 2013-07-05 |
| 44866 | ORIG | 2013-06-07 |
| 24107 | ORIG | 2013-06-07 |
| 32307 | ORIG | 2013-05-30 |
| 40221 | ORIG | 2013-05-29 |