Treats pain associated with true trigeminal neuralgia. ANDA 76729, held by Taro. Carbamazepine.
As of Nov 15, 2026, ANDA 76729 (Teril), held by Taro, was first approved by FDA on Sep 20, 2004, with 7 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: 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. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Teril100MG/5ML · suspension;oral | Carbamazepine | Rx |
| Feb 28, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 8, 2016 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 8, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jun 13, 2013 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 24, 2012 | Supplement 8Labeling | Approved | None posted |
| Jan 27, 2010 | Supplement 4Labeling | Approved | None posted |
| Apr 17, 2008 | Supplement 2Labeling | Approved | None posted |
| Sep 20, 2004 | 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
