Application 216655
- Type
- NDA
- Sponsor
- XIAMEN LP PHARM CO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPIPZA | ARIPIPRAZOLE | FILM;ORAL | 2MG | Yes | No |
| 002 | OPIPZA | ARIPIPRAZOLE | FILM;ORAL | 5MG | Yes | No |
| 003 | OPIPZA | ARIPIPRAZOLE | FILM;ORAL | 10MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81689 | SUPPL | 2025-03-24 |
| 81688 | SUPPL | 2025-03-24 |
| 81680 | SUPPL | 2025-03-24 |
| 80823 | ORIG | 2025-01-08 |
| 79172 | ORIG | 2024-07-24 |
| 79157 | ORIG | 2024-07-23 |