Application 212258
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TICAGRELOR | TICAGRELOR | TABLET;ORAL | 60MG | No | No |
| 002 | TICAGRELOR | TICAGRELOR | TABLET;ORAL | 90MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212258-001 | TICAGRELOR | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | |
| A212258-002 | TICAGRELOR | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212258-001 | AB |
| A212258-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-001 | TICAGRELOR | 60MG | TABLET / ORAL | AB | 2025-10-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-002 | TICAGRELOR | 90MG | TABLET / ORAL | AB | 2025-10-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A212258-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212258-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212258-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212258-002 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212258-002 | 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 |
|---|---|---|---|---|---|---|
| Ticagrelor | TICAGRELOR | Macleods Pharmaceuticals Limited | 32769721-c1dd-4bd3-90aa-a6cab59d3cd6 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 212258 ANDA212258 |
| Ticagrelor | TICAGRELOR | NorthStar RxLLC | c89c29c9-d2c0-4605-b74f-059e0b104977 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 212258 ANDA212258 |