Treats pain associated with true trigeminal neuralgia. ANDA 217277, held by Alkem Labs Ltd. Carbamazepine.
As of Nov 15, 2026, ANDA 217277 (Carbamazepine), held by Alkem Labs Ltd, was first approved by FDA on Jan 14, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Epilepsy Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2025 | 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 |
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
