Tegretol

Treats pain associated with true trigeminal neuralgia. NDA 18927, held by Novartis. Carbamazepine.

As of Nov 14, 2026, NDA 18927 (Tegretol), held by Novartis, was first approved by FDA on Dec 18, 1987, with 44 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1987
Review: Standard
Supplements approved: 44
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below


Oct 11, 1995	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 18, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tegretol100MG/5ML · suspension;oral	Carbamazepine	RxReference drug

All 45 submissions, including labeling and manufacturing supplements


Jul 15, 2026	Supplement 63Labeling · Standard review	Approved	Label Letter
Sep 30, 2025	Supplement 61Labeling · Standard review	Approved	Letter Label
Sep 13, 2023	Supplement 60Labeling · Standard review	Approved	Letter Label
Mar 20, 2018	Supplement 55Labeling · Standard review	Approved	Medication Guide Label Letter
Jul 8, 2016	Supplement 52Manufacturing · Standard review	Approved	None posted
Jun 17, 2016	Supplement 51Manufacturing · Standard review	Approved	None posted
Aug 28, 2015	Supplement 38Labeling · Standard review	Approved	Label Letter
Sep 16, 2014	Supplement 40Labeling · Standard review	Approved	Label Letter
Jan 16, 2014	Supplement 44Labeling	Approved	Letter Label
Nov 8, 2013	Supplement 49Manufacturing · Standard review	Approved	None posted
Mar 6, 2013	Supplement 46Labeling · Standard review	Approved	Letter Label
Dec 11, 2012	Supplement 48Labeling · Standard review	Approved	Label Letter
Oct 30, 2011	Supplement 47REMS	Approved	Letter
Mar 3, 2011	Supplement 42Labeling · Standard review	Approved	Label Letter
Mar 3, 2011	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 43Labeling	Approved	Label Letter
Dec 11, 2007	Supplement 39Labeling · Standard review	Approved	Letter Label
Aug 16, 2007	Supplement 35Labeling · Standard review	Approved	Label Letter
Dec 11, 2002	Supplement 34Manufacturing · Standard review	Approved	None posted
Jan 28, 2002	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 15, 2001	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 7, 2001	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 11, 2000	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 10, 2000	Supplement 28Labeling · Standard review	Approved	None posted
Apr 10, 2000	Supplement 24Labeling · Standard review	Approved	None posted
Mar 8, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 19, 1999	Supplement 26Manufacturing · Standard review	Approved	None posted
Dec 29, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 15, 1998	Supplement 25Labeling · Standard review	Approved	None posted
Jul 15, 1998	Supplement 23Labeling · Standard review	Approved	None posted
Jul 15, 1998	Supplement 21Labeling · Standard review	Approved	None posted
Jul 15, 1998	Supplement 20Labeling · Standard review	Approved	None posted
Jan 2, 1997	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 11, 1995	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 9, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 6, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 14, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 26, 1990	Supplement 8Labeling	Approved	None posted
Aug 1, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 21, 1989	Supplement 5Labeling	Approved	None posted
Apr 7, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 1, 1988	Supplement 3Labeling	Approved	None posted
Jul 28, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 28, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 18, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18927
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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