Treats pain associated with true trigeminal neuralgia. ANDA 76697, held by Ani Pharms. Carbamazepine.
As of Nov 15, 2026, ANDA 76697 (Carbamazepine), held by Ani Pharms, was first approved by FDA on May 20, 2011, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release capsules 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: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements 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 |
|---|---|---|---|
| May 20, 2011 | Original application | Approved |
| Carbamazepine100MG · capsule, extended release;oral | Carbamazepine | Rx |
| Carbamazepine200MG · capsule, extended release;oral | Carbamazepine | Rx |
| Carbamazepine300MG · capsule, extended release;oral | Carbamazepine | Rx |
| Jan 29, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 9, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 9, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 9, 2022 | Supplement 16Labeling · Standard review | Approved | None posted |
| Feb 18, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 20, 2011 | Original application | Approved |
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
