Application 202103
- Type
- ANDA
- Sponsor
- APOTEX INC
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 | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202103-001 | DASATINIB | DASATINIB | 20MG | TABLET / ORAL | AB | 2016-06-10 | |
| A202103-002 | DASATINIB | DASATINIB | 50MG | TABLET / ORAL | AB | 2016-06-10 | |
| A202103-003 | DASATINIB | DASATINIB | 70MG | TABLET / ORAL | AB | 2016-06-10 | |
| A202103-004 | DASATINIB | DASATINIB | 100MG | TABLET / ORAL | AB | 2016-06-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202103-001 | AB |
| A202103-002 | AB |
| A202103-003 | AB |
| A202103-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A202103-001 | DASATINIB | 20MG | TABLET / ORAL | 2016-06-10 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202103-002 | DASATINIB | 50MG | TABLET / ORAL | 2016-06-10 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202103-003 | DASATINIB | 70MG | TABLET / ORAL | 2016-06-10 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202103-004 | DASATINIB | 100MG | TABLET / ORAL | 2016-06-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202103-001 | DASATINIB | 20MG | TABLET / ORAL | 2016-06-10 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202103-002 | DASATINIB | 50MG | TABLET / ORAL | 2016-06-10 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202103-003 | DASATINIB | 70MG | TABLET / ORAL | 2016-06-10 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202103-004 | DASATINIB | 100MG | TABLET / ORAL | 2016-06-10 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202103-001 | DASATINIB | 20MG | TABLET / ORAL | 2016-06-10 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202103-002 | DASATINIB | 50MG | TABLET / ORAL | 2016-06-10 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202103-003 | DASATINIB | 70MG | TABLET / ORAL | 2016-06-10 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202103-004 | DASATINIB | 100MG | TABLET / ORAL | 2016-06-10 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202103-001 | DASATINIB | 20MG | TABLET / ORAL | AB | 2016-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202103-002 | DASATINIB | 50MG | TABLET / ORAL | AB | 2016-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202103-003 | DASATINIB | 70MG | TABLET / ORAL | AB | 2016-06-10 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202103-004 | DASATINIB | 100MG | TABLET / ORAL | AB | 2016-06-10 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A202103-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A202103-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A202103-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A202103-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A202103-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202103-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202103-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202103-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202103-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202103-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202103-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202103-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202103-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202103-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202103-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202103-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-004 | AB | 1 | 2680178bc6a6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-001 | PC | 2025-03-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-002 | PC | 2025-03-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-003 | PC | 2025-03-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202103-004 | PC | 2025-03-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-001 | PC | 2025-03-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-002 | PC | 2025-03-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-003 | PC | 2025-03-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202103-004 | PC | 2025-03-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-001 | PC | 2025-03-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-002 | PC | 2025-03-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-003 | PC | 2025-03-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202103-004 | PC | 2025-03-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-001 | PC | 2025-03-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-002 | PC | 2025-03-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-003 | PC | 2025-03-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202103-004 | PC | 2025-03-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-001 | PC | 2025-03-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-002 | PC | 2025-03-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-003 | PC | 2025-03-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202103-004 | PC | 2025-03-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-001 | PC | 2025-03-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-002 | PC | 2025-03-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-003 | PC | 2025-03-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202103-004 | PC | 2025-03-02 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202103-001 | PC | 2025-03-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202103-002 | PC | 2025-03-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202103-003 | PC | 2025-03-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202103-004 | PC | 2025-03-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202103-001 | PC | 2025-03-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202103-002 | PC | 2025-03-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202103-003 | PC | 2025-03-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202103-004 | PC | 2025-03-02 | d06236e962d9… |
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 | Apotex Corp. | 2ed87763-f018-abdb-c0ab-daa5e441b397 | 2024-09-04 | Warnings, Adverse reactions | 202103 ANDA202103 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.