Application 213562
- Type
- ANDA
- Sponsor
- AMNEAL EU LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 0.25MG | No | No |
| 002 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No |
| 003 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No |
| 004 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No |
| 005 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No |
| 006 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213562-001 | BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | ||
| A213562-002 | BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | ||
| A213562-003 | BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | ||
| A213562-004 | BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | ||
| A213562-005 | BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | ||
| A213562-006 | BREXPIPRAZOLE | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 |
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 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213562-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2023-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213562-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2023-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213562-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2023-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213562-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2023-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213562-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2023-01-31 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | 6991c065-0f6e-433a-8f4f-796e0ece327f | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Rexulti | BREXPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | 2d301358-6291-4ec1-bd87-37b4ad9bd850 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | df891816-3fdb-4347-8bf0-c18bc40f1d70 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Brexpiprazole | BREXPIPRAZOLE | Ajanta Pharma USA Inc. | 993b584c-7fe6-4551-899f-39146c8508ac | 2022-12-13 | Boxed warning, Warnings, Adverse reactions | Brexpiprazole BREXPIPRAZOLE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69660 | ORIG | 2021-12-20 |