Application 218719
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DASATINIB | DASATINIB | TABLET;ORAL | 20MG | No | No |
| 002 | DASATINIB | DASATINIB | TABLET;ORAL | 50MG | No | No |
| 003 | DASATINIB | DASATINIB | TABLET;ORAL | 70MG | No | No |
| 004 | DASATINIB | DASATINIB | TABLET;ORAL | 80MG | No | No |
| 005 | DASATINIB | DASATINIB | TABLET;ORAL | 100MG | No | No |
| 006 | DASATINIB | DASATINIB | TABLET;ORAL | 140MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218719-001 | DASATINIB | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | |
| A218719-002 | DASATINIB | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | |
| A218719-003 | DASATINIB | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | |
| A218719-004 | DASATINIB | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | |
| A218719-005 | DASATINIB | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | |
| A218719-006 | DASATINIB | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218719-001 | AB |
| A218719-002 | AB |
| A218719-003 | AB |
| A218719-004 | AB |
| A218719-005 | AB |
| A218719-006 | AB |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218719-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-004 | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-005 | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-006 | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-004 | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-005 | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-006 | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-004 | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-005 | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-006 | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-004 | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-005 | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-006 | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-004 | DASATINIB | 80MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-005 | DASATINIB | 100MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-006 | DASATINIB | 140MG | TABLET / ORAL | AB | 2025-03-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218719-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218719-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218719-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218719-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218719-006 | AB | 1 | fd3edfee7708… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218719-006 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| dasatinib | DASATINIB | Zydus Lifesciences Limited | 4eed6b7b-a09d-4d2e-a345-968dd68323bc | 2025-03-04 | 218719 ANDA218719 | |
| dasatinib | DASATINIB | Zydus Pharmaceuticals USA Inc. | 11703145-29ea-480a-9810-bc70663b783f | 2024-09-10 | Warnings, Adverse reactions | 218719 ANDA218719 |