Treats pain associated with true trigeminal neuralgia. ANDA 215591, held by Zhejiang Jiuzhou. Carbamazepine.
As of Nov 15, 2026, ANDA 215591 (Carbamazepine), held by Zhejiang Jiuzhou, was first approved by FDA on Mar 31, 2022, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2022 | Original application | Approved | None posted |
| Carbamazepine100MG · tablet, extended release;oral | Carbamazepine | Rx |
| Carbamazepine200MG · tablet, extended release;oral | Carbamazepine | Rx |
| Carbamazepine400MG · tablet, extended release;oral | Carbamazepine | Rx |
| Jun 26, 2026 | Supplement 9Manufacturing | Approved | None posted |
| Aug 15, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 31, 2022 | Original application | Approved | None posted |
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
