Treats partial-onset seizures. ANDA 211186, held by Hetero Labs Ltd V. Eslicarbazepine Acetate.
As of Nov 15, 2026, ANDA 211186 (Eslicarbazepine Acetate), held by Hetero Labs Ltd V, was first approved by FDA on Aug 3, 2023, with 0 approved supplements and 0 published complete response letters.
Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2023 | Original application | Approved | None posted |
| Eslicarbazepine Acetate200MG · tablet;oral | Eslicarbazepine Acetate | Rx |
| Eslicarbazepine Acetate400MG · tablet;oral | Eslicarbazepine Acetate | Rx |
| Eslicarbazepine Acetate600MG · tablet;oral | Eslicarbazepine Acetate | Rx |
| Eslicarbazepine Acetate800MG · tablet;oral | Eslicarbazepine Acetate | Rx |
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
