Application 217248
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 004 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |