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 | APOZEAL PHARMACEUTICALS INC | 4ab6d256-6590-45be-a5df-f505987f96c3 | 2026-08-30 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Amerisyn LLC | 58b7504f-c4a3-ef1b-e063-6394a90ac0f3 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals LLC | d526af85-ee70-4657-a27e-d451027ffd9e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 5643c32b-310e-4888-e063-6394a90ab62f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | ATLANTIC BIOLOGICALS CORP. | dc8c6638-f487-49df-a265-78caa93e43d8 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee495f20-c668-4d8f-9684-1029a4f232db | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Coupler LLC | 55f3ebec-a742-48fc-e063-6394a90a1452 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | ANI Pharmaceuticals, Inc. | 1f47ec91-602f-4fba-8f7e-a5698760b655 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 03d3b52d-3a7d-4595-84c9-332da6ca9171 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | c84807bd-35d7-4138-8989-42617d69293a | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERDAL | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 7e117c7e-02fc-4343-92a1-230061dfc5e0 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Rykindo extended-release microspheres | RISPERIDONE | Shandong Luye Pharmaceutical Co., Ltd. | 58534c96-96f5-4c2e-a061-92d4506aee91 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | e72a2768-815f-47bf-b2f9-16a93dd10684 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 50216d94-7667-bd6a-e063-6394a90a8155 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| risperidone | RISPERIDONE | Cardinal Health 107, LLC | 3ce21196-4aa0-469b-8f04-6650b2c48cb5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Solco Healthcare US, LLC | 43aa2a4f-1123-4f86-800b-9218882f7bcd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.