Application 213586
- Type
- NDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 50MG/0.14ML (50MG/0.14ML) | Yes | Yes |
| 002 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 75MG/0.21ML (75MG/0.21ML) | Yes | Yes |
| 003 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 100MG/0.28ML (100MG/0.28ML) | Yes | Yes |
| 004 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 125MG/0.35ML (125MG/0.35ML) | Yes | Yes |
| 005 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 150MG/0.42ML (150MG/0.42ML) | Yes | Yes |
| 006 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 200MG/0.56ML (200MG/0.56ML) | Yes | Yes |
| 007 | UZEDY | RISPERIDONE | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 250MG/0.7ML (250MG/0.7ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213586-001 | UZEDY | RISPERIDONE | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-002 | UZEDY | RISPERIDONE | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-003 | UZEDY | RISPERIDONE | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-004 | UZEDY | RISPERIDONE | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-005 | UZEDY | RISPERIDONE | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-006 | UZEDY | RISPERIDONE | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | |
| N213586-007 | UZEDY | RISPERIDONE | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213586-001 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-001 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 |
| N213586-001 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-001 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-001 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-001 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 |
| N213586-001 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-001 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 |
| N213586-001 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-002 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-002 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 |
| N213586-002 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-002 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-002 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-002 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 |
| N213586-002 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-002 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 |
| N213586-002 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-003 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-003 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 |
| N213586-003 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-003 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-003 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-003 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 |
| N213586-003 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-003 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 |
| N213586-003 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-004 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-004 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-004 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-004 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-004 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-004 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-005 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-005 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-005 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-005 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-005 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-005 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-006 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-006 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-006 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-006 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-006 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-006 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | |
| N213586-007 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-007 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 |
| N213586-007 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | |
| N213586-007 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 |
| N213586-007 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 |
| N213586-007 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N213586-001 | NP | 2026-04-28 |
| N213586-002 | NP | 2026-04-28 |
| N213586-003 | NP | 2026-04-28 |
| N213586-004 | NP | 2026-04-28 |
| N213586-005 | NP | 2026-04-28 |
| N213586-006 | NP | 2026-04-28 |
| N213586-007 | NP | 2026-04-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-006 | UZEDY | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-007 | UZEDY | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-006 | UZEDY | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213586-007 | UZEDY | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-006 | UZEDY | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-007 | UZEDY | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-006 | UZEDY | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-007 | UZEDY | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-006 | UZEDY | 200MG/0.56ML (200MG/0.56ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-007 | UZEDY | 250MG/0.7ML (250MG/0.7ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-001 | UZEDY | 50MG/0.14ML (50MG/0.14ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-002 | UZEDY | 75MG/0.21ML (75MG/0.21ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-003 | UZEDY | 100MG/0.28ML (100MG/0.28ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-004 | UZEDY | 125MG/0.35ML (125MG/0.35ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-005 | UZEDY | 150MG/0.42ML (150MG/0.42ML) | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | RLD, RS | 2023-04-28 | fd3edfee7708… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 8221778 | 2027-11-12 | U-601 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 12128132 | 2040-09-11 | U-601 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 12383493 | 2040-09-11 | U-601 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 8741327 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 9023897 | 2033-04-05 | Drug product | 2023-05-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 12128132 | 2040-09-11 | U-543 | Drug product | 2024-11-18 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 12383493 | 2040-09-11 | U-543 | Drug product | 2025-09-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | 12329851 | 2042-03-17 | U-4214 | 2025-07-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213586-006 | 8221778 | 2027-11-12 | U-543 | Drug product | 2023-05-03 | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213586-001 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-002 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-003 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-004 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-005 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-006 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N213586-007 | NP | 2026-04-28 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-001 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-002 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-003 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-004 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-005 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-006 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N213586-007 | NP | 2026-04-28 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-001 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-002 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-003 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-004 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-005 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-006 | NP | 2026-04-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N213586-007 | NP | 2026-04-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-001 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-002 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-003 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-004 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-005 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-006 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213586-007 | NP | 2026-04-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-001 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-002 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-003 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-004 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-005 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-006 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N213586-007 | NP | 2026-04-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-001 | NP | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-002 | NP | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-003 | NP | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-004 | NP | 2026-04-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213586-005 | NP | 2026-04-28 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | Amici Pharma, Inc. | ca41c144-224a-4d57-88d7-8778e6c69ed2 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Torrent Pharmaceuticals Limited | a6347895-5f16-43b4-92a0-b9904ac81937 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| risperidone | RISPERIDONE | Lupin Pharmaceuticals, Inc. | b462e48c-ef1d-4591-8fca-6b5829d8ed90 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 2776a647-678d-465c-9db3-4a9459ce779e | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 5d9519af-5a5e-47ce-8a0f-9b9cfac00e19 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee7d6779-7421-4761-99d2-ccbfde9385a8 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 101b2d4d-4740-4225-94bc-aecc05d82c6b | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Par Health USA, LLC | d0ef6df3-67e5-47b1-bcf7-f67aa030caca | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| risperidone | RISPERIDONE | Major Pharmaceuticals | d5abd75f-7f4a-4a7d-b849-82fce88f5ff7 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Westminster Pharmaceuticals, LLC | 07d43bf6-a695-453a-a5c7-9581effe585c | 2025-12-07 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Golden State Medical Supply, Inc. | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | American Health Packaging | f11dae15-b057-4258-9229-3819d0c980fe | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERDAL CONSTA | RISPERIDONE | Janssen Pharmaceuticals, Inc. | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Jubilant Cadista Pharmacuticals Inc. | 739dcf8a-ed73-5eb0-899b-7e51cb73c335 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | 095630bd-a77e-434e-94ee-f13da445d8f2 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | AvKARE | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 4604052d-dbda-4535-b7b8-1bd72a129aca | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | NuCare Pharmaceuticals, Inc. | 390904c2-fcfa-466e-e063-6394a90a03af | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Jubilant Cadista Pharmacuticals Inc. | 39d41b28-93eb-446b-9652-7432858ccbab | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.