Application 212124
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 002 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
| 003 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No |
| 005 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212124-001 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | |
| A212124-002 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | |
| A212124-003 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | |
| A212124-004 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | |
| A212124-005 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212124-001 | AB |
| A212124-002 | AB |
| A212124-003 | AB |
| A212124-004 | AB |
| A212124-005 | 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 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-001 | LURASIDONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2023-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-002 | LURASIDONE HYDROCHLORIDE | 40MG | TABLET / ORAL | AB | 2023-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-003 | LURASIDONE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2023-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-004 | LURASIDONE HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2023-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-005 | LURASIDONE HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2023-06-09 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212124-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212124-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212124-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212124-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212124-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212124-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212124-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212124-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212124-005 | AB | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 2b07a830-93ba-427a-95fc-5138a6309f1e | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 212124 ANDA212124 |
| lurasidone hydrochloride | LURASIDONE HYDROCHLORIDE | NorthStar RxLLC | 10a88607-0b5e-4707-b0cb-40c58a5c6774 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 212124 ANDA212124 |