Application 211024
- Type
- ANDA
- Sponsor
- PRINSTON PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VORTIOXETINE | VORTIOXETINE | TABLET;ORAL | 5MG | No | No |
| 002 | VORTIOXETINE | VORTIOXETINE | TABLET;ORAL | 10MG | No | No |
| 003 | VORTIOXETINE | VORTIOXETINE | TABLET;ORAL | 15MG | No | No |
| 004 | VORTIOXETINE | VORTIOXETINE | TABLET;ORAL | 20MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71963 | ORIG | 2022-08-30 |