Application 204159
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 003 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 100MG | No | No |
| 004 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 140MG | No | No |
| 005 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 180MG | No | No |
| 006 | TEMOZOLOMIDE | TEMOZOLOMIDE | CAPSULE;ORAL | 250MG | No | No |