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 | NCS HealthCare of KY, LLC dba Vangard Labs | 7bbc37f1-6d6a-4021-8976-1f103ce1cfbd | 2023-02-27 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | bda104ac-1eea-4a1a-836a-24bcc034b90f | 2022-11-09 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 088dc3dd-7740-471b-8c06-5a47900ae5b5 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 1b5c9889-4dc3-48df-8629-4ac099e2b4c0 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Sun Pharmaceutical Industries, Inc. | f91f551e-926f-440d-83d2-357e9d7484fe | 2022-07-13 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 394c7e27-52a2-4d4c-8c6e-fe37b03266ae | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| risperidone | RISPERIDONE | Proficient Rx LP | b611fe52-1787-47e6-8a6b-1999a4e4f22c | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | ac152803-d75f-4c3c-bc49-8663b21a3a82 | 2019-04-29 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | 58e422ec-da66-41b0-83c1-aefd940beda0 | 2019-04-10 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.