NDA 18281, held by Novartis. Carbamazepine.
As of Nov 13, 2026, NDA 18281 (Tegretol), held by Novartis, was first approved by FDA on Dec 14, 1981, with 46 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 1995 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Dec 14, 1981 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tegretol100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Carbamazepine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2018 | Supplement 58Labeling · Standard review | Approved | |
| Aug 28, 2015 | Supplement 45Labeling · Standard review | Approved | |
| Sep 16, 2014 | Supplement 47Labeling · Standard review | Approved | |
| Jan 16, 2014 | Supplement 51Labeling | Approved | |
| Nov 8, 2013 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Mar 6, 2013 | Supplement 53Labeling · Standard review | Approved | |
| Dec 11, 2012 | Supplement 55Labeling · Standard review | Approved | |
| Oct 30, 2011 | Supplement 54REMS | Approved | None posted |
| Mar 3, 2011 | Supplement 49Labeling · Standard review | Approved | |
| Mar 3, 2011 | Supplement 50Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 48Labeling | Approved | |
| Dec 11, 2007 | Supplement 46Labeling · Standard review | Approved | |
| Aug 16, 2007 | Supplement 44Labeling · Standard review | Approved | |
| Mar 5, 2002 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 28, 2002 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Nov 15, 2001 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Mar 7, 2001 | Supplement 39Labeling · Standard review | Approved | |
| May 18, 2000 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2000 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 37Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 33Labeling · Standard review | Approved | None posted |
| Apr 23, 1999 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1999 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 34Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 32Labeling · Standard review | Approved | None posted |
| Jul 15, 1998 | Supplement 31Labeling · Standard review | Approved | |
| Jul 15, 1998 | Supplement 30Labeling · Standard review | Approved | None posted |
| Oct 11, 1995 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Feb 3, 1995 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1993 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 23, 1992 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1991 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1990 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1990 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1990 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1990 | Supplement 18Labeling | Approved | None posted |
| Jul 21, 1989 | Supplement 13Labeling | Approved | None posted |
| Apr 7, 1989 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1988 | Supplement 11Labeling | Approved | None posted |
| Jul 31, 1987 | Supplement 9Labeling | Approved | None posted |
| Sep 11, 1986 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1986 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1986 | Supplement 5Labeling | Approved | None posted |
| Jan 10, 1986 | Supplement 4Labeling | Approved | None posted |
| Jun 21, 1983 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1982 | Supplement 1Labeling | Approved | None posted |
| Dec 14, 1981 | Original applicationNew dosage form · Standard review | 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
