Treats pain associated with true trigeminal neuralgia. ANDA 211623, held by Unique Pharm. Carbamazepine.
As of Nov 15, 2026, ANDA 211623 (Carbamazepine), held by Unique Pharm, was first approved by FDA on Apr 24, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Carbamazepine Extended-Release Tablet 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2020 | 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 |
| Jan 29, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 24, 2020 | 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
