Treats pain associated with true trigeminal neuralgia. NDA 16608, held by Novartis. Carbamazepine.
As of Nov 14, 2026, NDA 16608 (Tegretol), held by Novartis, was first approved by FDA on Mar 11, 1968, with 86 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).
| Oct 11, 1995 | Supplement 59Efficacy (new indication or use) | Approved | None posted |
| Jul 31, 1987 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| Jun 2, 1986 | Supplement 54Efficacy (new indication or use) | Approved | None posted |
| Mar 11, 1968 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tegretol200MG · tablet;oral | Carbamazepine | RxReference drug |
| Jul 15, 2026 | Supplement 124Labeling · Standard review | Approved | |
| Sep 30, 2025 | Supplement 122Labeling · Standard review | Approved | |
| Sep 13, 2023 | Supplement 121Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 116Labeling · Standard review | Approved | |
| Oct 30, 2015 | Supplement 111Manufacturing · Priority review | Approved | None posted |
| Aug 28, 2015 | Supplement 97Labeling · Standard review | Approved | |
| Sep 16, 2014 | Supplement 99Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 103Labeling | Approved | |
| Nov 8, 2013 | Supplement 108Manufacturing · Priority review | Approved | None posted |
| Mar 6, 2013 | Supplement 105Labeling · Standard review | Approved | |
| Dec 11, 2012 | Supplement 107Labeling · Standard review | Approved | |
| Oct 30, 2011 | Supplement 106REMS | Approved | |
| Mar 3, 2011 | Supplement 100Labeling · Standard review | Approved | |
| Mar 3, 2011 | Supplement 102Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 101Labeling | Approved | |
| Dec 11, 2007 | Supplement 98Labeling · Standard review | Approved | |
| Aug 16, 2007 | Supplement 96Labeling · Standard review | Approved | |
| Jan 28, 2002 | Supplement 94Manufacturing · Priority review | Approved | None posted |
| Nov 19, 2001 | Supplement 92Manufacturing · Priority review | Approved | None posted |
| Nov 15, 2001 | Supplement 93Manufacturing · Priority review | Approved | None posted |
| Mar 7, 2001 | Supplement 90Labeling · Standard review | Approved | |
| May 18, 2000 | Supplement 91Manufacturing · Priority review | Approved | None posted |
| Apr 11, 2000 | Supplement 89Manufacturing · Priority review | Approved | None posted |
| Apr 10, 2000 | Supplement 84Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 88Labeling · Standard review | Approved | None posted |
| Jun 7, 1999 | Supplement 87Manufacturing · Priority review | Approved | None posted |
| Apr 21, 1999 | Supplement 86Manufacturing · Priority review | Approved | None posted |
| Jul 15, 1998 | Supplement 80Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 81Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 83Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 85Labeling · Standard review | Approved | None posted |
| Mar 6, 1997 | Supplement 82Manufacturing · Priority review | Approved | None posted |
| Oct 11, 1995 | Supplement 59Efficacy (new indication or use) | Approved | None posted |
| Oct 5, 1995 | Supplement 79Manufacturing · Priority review | Approved | None posted |
| Oct 6, 1993 | Supplement 77Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1991 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jun 1, 1990 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Mar 28, 1990 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Mar 28, 1990 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Mar 27, 1990 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Mar 26, 1990 | Supplement 68Labeling | Approved | None posted |
| Jul 21, 1989 | Supplement 63Labeling | Approved | None posted |
| Apr 7, 1989 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Aug 8, 1988 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| Aug 1, 1988 | Supplement 61Labeling | Approved | None posted |
| Jul 31, 1987 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| Jul 31, 1987 | Supplement 58Labeling | Approved | None posted |
| Jun 2, 1986 | Supplement 54Efficacy (new indication or use) | Approved | None posted |
| Feb 3, 1986 | Supplement 56Labeling | Approved | None posted |
| Jan 10, 1986 | Supplement 53Labeling | Approved | None posted |
| Jan 10, 1986 | Supplement 55Labeling | Approved | None posted |
| May 6, 1985 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Mar 8, 1985 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1984 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Sep 14, 1983 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Jul 8, 1982 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Feb 9, 1982 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Dec 8, 1981 | Supplement 45Labeling | Approved | None posted |
| Mar 25, 1980 | Supplement 42Labeling | Approved | None posted |
| Feb 1, 1980 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Apr 9, 1979 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1978 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1978 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Aug 9, 1978 | Supplement 36Labeling | Approved | None posted |
| Aug 9, 1978 | Supplement 37Labeling | Approved | None posted |
| Apr 4, 1977 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1977 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1977 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Nov 8, 1976 | Supplement 28Labeling | Approved | None posted |
| Dec 12, 1975 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Dec 9, 1975 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Jul 2, 1975 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Mar 31, 1975 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Mar 28, 1975 | Supplement 23Labeling | Approved | None posted |
| Dec 12, 1974 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Nov 15, 1974 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Nov 8, 1974 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1974 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Aug 20, 1974 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jul 15, 1974 | Supplement 12Labeling | Approved | None posted |
| Mar 11, 1968 | Original applicationNew molecular entity · Priority 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
