FDA.reportPublic FDA data

Application 219002

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMETINIB DIMETHYL SULFOXIDETRAMETINIB DIMETHYL SULFOXIDETABLET;ORALEQ 0.5MGNoNo
002TRAMETINIB DIMETHYL SULFOXIDETRAMETINIB DIMETHYL SULFOXIDETABLET;ORALEQ 2MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219002-001TRAMETINIB DIMETHYL SULFOXIDETRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06
A219002-002TRAMETINIB DIMETHYL SULFOXIDETRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORALAB2024-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORALAB2024-08-0679d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219002-001TRAMETINIB DIMETHYL SULFOXIDEEQ 0.5MGTABLET / ORAL2024-08-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219002-002TRAMETINIB DIMETHYL SULFOXIDEEQ 2MGTABLET / ORAL2024-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A219002-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A219002-002AB179d66fd596c7…