Treats pain associated with true trigeminal neuralgia. NDA 20234, held by Novartis. Carbamazepine.
As of Nov 13, 2026, NDA 20234 (Tegretol-Xr), held by Novartis, was first approved by FDA on Mar 25, 1996, with 38 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Epilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol 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 Tegretol (see PRECAUTIONS, General).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 25, 1996 | Original applicationNew dosage form · Standard review | Approved |
| Tegretol-Xr100MG · tablet, extended release;oral | Carbamazepine | RxReference drug |
| Tegretol-Xr200MG · tablet, extended release;oral | Carbamazepine | RxReference drug |
| Tegretol-Xr400MG · tablet, extended release;oral | Carbamazepine | RxReference drug |
| Jul 15, 2026 | Supplement 57Labeling · Standard review | Approved | |
| Sep 30, 2025 | Supplement 55Labeling · Standard review | Approved | |
| Sep 13, 2023 | Supplement 54Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 47Labeling · Standard review | Approved | |
| Aug 28, 2015 | Supplement 26Labeling · Standard review | Approved | |
| Sep 16, 2014 | Supplement 30Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 35Labeling | Approved | |
| Jul 29, 2013 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Mar 6, 2013 | Supplement 38Labeling · Standard review | Approved | |
| Dec 11, 2012 | Supplement 40Labeling · Standard review | Approved | |
| Oct 30, 2011 | Supplement 39REMS | Approved | |
| Mar 3, 2011 | Supplement 33Labeling · Standard review | Approved | |
| Mar 3, 2011 | Supplement 31Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 32Labeling | Approved | |
| Dec 11, 2007 | Supplement 28Labeling · Standard review | Approved | |
| Aug 16, 2007 | Supplement 25Labeling · Standard review | Approved | |
| May 6, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 28, 2002 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 15, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 7, 2001 | Supplement 17Labeling · Standard review | Approved | |
| Feb 22, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 11, 2001 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2000 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 7, 2000 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1999 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1999 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 24, 1996 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1996 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 24, 1996 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1996 | Original applicationNew dosage form · Standard review | 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
