Treats pain associated with true trigeminal neuralgia. ANDA 212948, held by Anbison Lab. Carbamazepine.
As of Nov 15, 2026, ANDA 212948 (Carbamazepine), held by Anbison Lab, was first approved by FDA on Sep 30, 2021, with 0 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: 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. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2021 | 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
