Application 205444
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 150MG | No | No |
| 002 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 003 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55403 | ORIG | 2018-09-07 |