Application 218492
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 2MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81202 | ORIG | 2025-02-10 |