Application 204114
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 0.5MG | Yes | No |
| 002 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 1MG | Yes | No |
| 003 | MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 2MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0666 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0668 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1105 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1105 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1105 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1105 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1112 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1112 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1112 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-1112 | Mekinist | trametinib | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85933 | SUPPL | 2026-05-18 |
| 85868 | SUPPL | 2026-05-11 |
| 85591 | SUPPL | 2026-03-30 |
| 85569 | SUPPL | 2026-03-30 |
| 81989 | SUPPL | 2025-04-25 |
| 81987 | SUPPL | 2025-04-25 |
| 81910 | SUPPL | 2025-04-09 |
| 81836 | SUPPL | 2025-04-08 |
| 81666 | SUPPL | 2025-03-21 |
| 81524 | SUPPL | 2025-03-21 |
| 81656 | SUPPL | 2025-03-20 |
| 81512 | SUPPL | 2025-03-11 |
| 81290 | SUPPL | 2025-02-20 |
| 81256 | SUPPL | 2025-02-14 |
| 79969 | SUPPL | 2024-10-24 |
| 79810 | SUPPL | 2024-10-03 |
| 79093 | SUPPL | 2024-07-15 |
| 79057 | SUPPL | 2024-07-12 |
| 78023 | SUPPL | 2024-04-01 |
| 78011 | SUPPL | 2024-04-01 |
| 77646 | SUPPL | 2024-02-28 |
| 77636 | SUPPL | 2024-02-28 |
| 75347 | SUPPL | 2023-09-01 |
| 75338 | SUPPL | 2023-09-01 |
| 74402 | SUPPL | 2023-05-30 |
| 74401 | SUPPL | 2023-05-30 |
| 74396 | SUPPL | 2023-05-30 |
| 73796 | SUPPL | 2023-03-17 |
| 73778 | SUPPL | 2023-03-16 |
| 71433 | SUPPL | 2022-06-23 |
| 71429 | SUPPL | 2022-06-23 |
| 71197 | SUPPL | 2022-06-01 |
| 71172 | SUPPL | 2022-05-31 |
| 70039 | SUPPL | 2022-02-01 |
| 70034 | SUPPL | 2022-02-01 |
| 70016 | SUPPL | 2022-01-31 |
| 70015 | SUPPL | 2022-01-31 |
| 69500 | SUPPL | 2021-12-07 |
| 69490 | SUPPL | 2021-12-07 |
| 67462 | SUPPL | 2021-05-12 |
| 67452 | SUPPL | 2021-05-11 |
| 63690 | SUPPL | 2020-06-24 |
| 63681 | SUPPL | 2020-06-24 |
| 62575 | SUPPL | 2020-04-15 |
| 62538 | SUPPL | 2020-04-10 |
| 60458 | SUPPL | 2019-10-09 |
| 60265 | SUPPL | 2019-10-07 |
| 59368 | SUPPL | 2019-07-18 |
| 59366 | SUPPL | 2019-07-17 |
| 54043 | SUPPL | 2018-05-08 |
| 54016 | SUPPL | 2018-05-04 |
| 53991 | SUPPL | 2018-05-03 |
| 53872 | SUPPL | 2018-04-30 |
| 52996 | SUPPL | 2018-03-15 |
| 52922 | SUPPL | 2018-03-13 |
| 48835 | SUPPL | 2017-06-27 |
| 48810 | SUPPL | 2017-06-22 |
| 47436 | SUPPL | 2017-03-03 |
| 47338 | SUPPL | 2017-02-27 |
| 32513 | SUPPL | 2015-11-23 |
| 40356 | SUPPL | 2015-11-20 |
| 32512 | SUPPL | 2014-01-10 |
| 40355 | SUPPL | 2014-01-09 |
| 43456 | ORIG | 2013-07-08 |
| 24458 | ORIG | 2013-06-07 |
| 24120 | ORIG | 2013-06-07 |
| 32511 | ORIG | 2013-05-30 |
| 19528 | ORIG | 2013-05-29 |