Application 022172
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEROQUEL XR | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE; ORAL | 50MG | No | No |
| 002 | SEROQUEL XR | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE; ORAL | 200MG | No | No |
| 003 | SEROQUEL XR | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE; ORAL | 300MG | No | No |
| 004 | SEROQUEL XR | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE; ORAL | 400MG | No | No |