Treats pain associated with true trigeminal neuralgia. ANDA 216623, held by Alembic. Carbamazepine.
As of Nov 15, 2026, ANDA 216623 (Carbamazepine), held by Alembic, was first approved by FDA on Apr 16, 2025, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Carbamazepine tablets are 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 |
|---|---|---|---|
| Apr 16, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carbamazepine200MG · tablet;oral | Carbamazepine | Rx |
| Mar 20, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 16, 2025 | 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
