Application 212849
- Type
- NDA
- Sponsor
- SHANDONG LUYE PHARMACEUTICAL CO LTD
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84815 | SUPPL | 2026-01-22 |
| 84803 | SUPPL | 2026-01-21 |
| 81095 | SUPPL | 2025-02-06 |
| 81004 | SUPPL | 2025-02-05 |
| 77724 | ORIG | 2024-03-06 |
| 73202 | ORIG | 2023-01-17 |
| 73193 | ORIG | 2023-01-17 |