Application 213570
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 0.25MG | No | No |
| 002 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 0.50MG | No | No |
| 003 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 1MG | No | No |
| 004 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 2MG | No | No |
| 005 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 3MG | No | No |
| 006 | REXULTI | BREXPIPRAZOLE | TABLET; ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213570-001 | BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | ||
| A213570-002 | BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | ||
| A213570-003 | BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | ||
| A213570-004 | BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | ||
| A213570-005 | BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | ||
| A213570-006 | BREXPIPRAZOLE | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-003 | BREXPIPRAZOLE | 1MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-004 | BREXPIPRAZOLE | 2MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-005 | BREXPIPRAZOLE | 3MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213570-006 | BREXPIPRAZOLE | 4MG | TABLET / ORAL | 2022-09-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213570-001 | BREXPIPRAZOLE | 0.25MG | TABLET / ORAL | 2022-09-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213570-002 | BREXPIPRAZOLE | 0.5MG | TABLET / ORAL | 2022-09-26 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-005 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213570-006 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-004 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-005 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A213570-006 | AB | 1 | f41ea6bd6efb… |
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 | Rexulti BREXPIPRAZOLE |
| Rexulti | BREXPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | 2d301358-6291-4ec1-bd87-37b4ad9bd850 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | Rexulti BREXPIPRAZOLE |
| Brexpiprazole | BREXPIPRAZOLE | Ajanta Pharma USA Inc. | 993b584c-7fe6-4551-899f-39146c8508ac | 2022-12-13 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72161 | ORIG | 2022-09-27 |