ANDA 206576, held by Twi Pharms Inc. Oxcarbazepine.
As of Nov 15, 2026, ANDA 206576 (Oxcarbazepine), held by Twi Pharms Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2018 | Original application | Tentative approval | None posted |
| Oxcarbazepine150MG · tablet, extended release;oral | Oxcarbazepine | None (tentative approval) |
| Oxcarbazepine300MG · tablet, extended release;oral | Oxcarbazepine | None (tentative approval) |
| Oxcarbazepine600MG · tablet, extended release;oral | Oxcarbazepine | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters