Application 218755
- Type
- ANDA
- Sponsor
- ESKAYEF
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 002 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 003 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 6MG | No | No |
| 004 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83306 | ORIG | 2025-09-08 |