ANDA 211247, held by Sph Zhongxi Pharm. Eslicarbazepine Acetate.
As of Nov 15, 2026, ANDA 211247 (Eslicarbazepine Acetate), held by Sph Zhongxi Pharm, was first approved by FDA on Nov 3, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2025 | Original application | Approved |
| 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
