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 | Zydus Pharmaceuticals USA Inc. | 713b5ac7-53d6-4139-8599-3028f789de4b | 2025-06-14 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 684dcda4-d270-400c-9798-7d920a038bbb | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Cranbury Pharmaceuticals, LLC | a0a21bec-68f0-444e-a611-d0602859410c | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | be388943-fe0c-4c82-ac8e-3df9f77b2891 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | AvKARE | 2f9ea0cc-b86b-a11f-e063-6294a90a9620 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | c4582bdf-5eda-438c-98b4-0517500501e8 | 2025-03-04 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Teva Pharmaceuticals, Inc. | 32c0f081-b418-4c1c-b39e-eb5c344043c7 | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals NY LLC | e90c886c-132a-4df6-8604-cfe5ffa49d5b | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals LLC | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Direct_Rx | 0b784f21-fc02-6542-e063-6294a90a285e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| risperidone | RISPERIDONE | Zydus Lifesciences Limited | 23993d21-80bf-41c4-b57d-88a620173b6b | 2024-08-12 | RISPERIDONE | |
| RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | 79648a52-1364-c25b-e053-2a91aa0a8ea4 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 420cfeef-0061-43b9-9491-dbd6ad866e55 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | aab773b2-a605-4cf8-a301-57e390fe67a6 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 2f83d3e9-04ab-4b24-ad1f-7ed2e784298a | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | e35be034-6275-41fb-bec4-9ae451458701 | 2024-04-11 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Chartwell RX, LLC | 12a479c4-a84a-4308-b89f-be0315826fd5 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | 523d4f99-1d6f-413f-9d6e-2ca430aaac14 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Natco Pharma USA LLC | 856d65dc-f330-4195-b271-d0bdbe99519d | 2023-11-15 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.