Application 212849
- Type
- NDA
- Sponsor
- SHANDONG LUYE PHARMACEUTICAL CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYKINDO | RISERIDONE | INJECTION, SUSPENSION, EXTENDED RELEASE | 12.5MG | No | No |
| 002 | RYKINDO | RISERIDONE | INJECTION, SUSPENSION, EXTENDED RELEASE | 25MG | No | No |
| 003 | RYKINDO | RISERIDONE | INJECTION, SUSPENSION, EXTENDED RELEASE | 37.5MG | No | No |
| 004 | RYKINDO | RISERIDONE | INJECTION, SUSPENSION, EXTENDED RELEASE | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212849-001 | RYKINDO | RISPERIDONE | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 | |
| N212849-002 | RYKINDO | RISPERIDONE | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | |
| N212849-003 | RYKINDO | RISPERIDONE | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 | |
| N212849-004 | RYKINDO | RISPERIDONE | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212849-001 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-001 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-001 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | |
| N212849-001 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-001 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-002 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-002 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-002 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | |
| N212849-002 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-002 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-003 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-003 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-003 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | |
| N212849-003 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-003 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-004 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-004 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-004 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | |
| N212849-004 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
| N212849-004 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212849-001 | RYKINDO | 12.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212849-002 | RYKINDO | 25MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2023-01-13 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212849-003 | RYKINDO | 37.5MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212849-004 | RYKINDO | 50MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2023-01-13 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212849-001 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-001 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-001 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N212849-001 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-001 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-002 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-002 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-002 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N212849-002 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-002 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-003 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-003 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-003 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N212849-003 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-003 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-004 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-004 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-004 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N212849-004 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212849-004 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-001 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-001 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-001 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212849-001 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-001 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-002 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-002 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-002 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212849-002 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-002 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-003 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-003 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-003 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212849-003 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-003 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-004 | 10098882 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-004 | 10406161 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-004 | 11110094 | 2032-04-10 | Drug product | 2023-02-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212849-004 | 9446135 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212849-004 | 9532991 | 2032-04-10 | U-3513 | Drug product | 2023-02-07 | 84e616aacf4f… |
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 |
|---|---|---|---|---|---|---|
| Rykindo extended-release microspheres | RISPERIDONE | Shandong Luye Pharmaceutical Co., Ltd. | 58534c96-96f5-4c2e-a061-92d4506aee91 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 212849 NDA212849 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.