Epitol

Treats pain associated with true trigeminal neuralgia. ANDA 70541, held by Teva. Carbamazepine.

As of Nov 15, 2026, ANDA 70541 (Epitol), held by Teva, was first approved by FDA on Sep 17, 1986, with 52 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1986
Supplements approved: 52
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Epilepsy Carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 53 submissions below

Date	Submission	Status	Documents
Sep 17, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Epitol200MG · tablet;oral	Carbamazepine	Discontinued

All 53 submissions, including labeling and manufacturing supplements


Jul 22, 2024	Supplement 72Labeling · Standard review	Approved	None posted
Nov 21, 2022	Supplement 71Labeling · Standard review	Approved	None posted
Feb 27, 2020	Supplement 64Labeling · Standard review	Approved	None posted
Feb 27, 2020	Supplement 60Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 58Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 57Labeling · Standard review	Approved	None posted
Mar 10, 2014	Supplement 55Labeling · Standard review	Approved	None posted
Mar 10, 2014	Supplement 54Labeling · Standard review	Approved	None posted
Jul 9, 2013	Supplement 49Manufacturing	Approved	None posted
Jul 19, 2012	Supplement 53Labeling · Standard review	Approved	None posted
May 31, 2011	Supplement 52Labeling	Approved	None posted
Nov 4, 2009	Supplement 47Labeling	Approved	None posted
Mar 17, 2008	Supplement 46Labeling	Approved	None posted
Dec 5, 2002	Supplement 45Labeling	Approved	None posted
Aug 1, 2002	Supplement 43Manufacturing	Approved	None posted
Aug 1, 2002	Supplement 42Manufacturing	Approved	None posted
May 8, 2002	Supplement 44Labeling	Approved	None posted
May 1, 2000	Supplement 41Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 40Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 39Manufacturing	Approved	None posted
Aug 13, 1999	Supplement 32Labeling	Approved	None posted
Mar 12, 1999	Supplement 29Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 31Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 30Manufacturing	Approved	None posted
Jun 15, 1998	Supplement 27Manufacturing	Approved	None posted
Sep 24, 1997	Supplement 25Labeling	Approved	None posted
Sep 24, 1997	Supplement 28Labeling	Approved	None posted
May 1, 1997	Supplement 26Labeling	Approved	None posted
Jan 23, 1997	Supplement 24Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 23Manufacturing	Approved	None posted
Jul 25, 1996	Supplement 22Manufacturing	Approved	None posted
Feb 9, 1995	Supplement 21Labeling	Approved	None posted
Feb 18, 1993	Supplement 19Labeling	Approved	None posted
Jan 23, 1992	Supplement 8Manufacturing	Approved	None posted
Jan 23, 1992	Supplement 18Manufacturing	Approved	None posted
Dec 5, 1991	Supplement 13Manufacturing	Approved	None posted
Nov 30, 1990	Supplement 75Labeling	Approved	None posted
Nov 30, 1990	Supplement 17Labeling	Approved	None posted
Jan 19, 1990	Supplement 16Labeling	Approved	None posted
Aug 9, 1989	Supplement 12Labeling	Approved	None posted
Jun 9, 1989	Supplement 15Manufacturing	Approved	None posted
Apr 7, 1989	Supplement 9Manufacturing	Approved	None posted
Apr 7, 1989	Supplement 10Labeling	Approved	None posted
Apr 7, 1989	Supplement 11Manufacturing	Approved	None posted
Mar 11, 1988	Supplement 74Labeling	Approved	None posted
Mar 11, 1988	Supplement 4Manufacturing	Approved	None posted
Mar 11, 1988	Supplement 5Labeling	Approved	None posted
Mar 11, 1988	Supplement 6Manufacturing	Approved	None posted
Dec 17, 1987	Supplement 1Manufacturing	Approved	None posted
Dec 16, 1987	Supplement 7Manufacturing	Approved	None posted
Nov 9, 1987	Supplement 3Manufacturing	Approved	None posted
Feb 17, 1987	Supplement 2Labeling	Approved	None posted
Sep 17, 1986	Original application	Approved	None posted

Show all 53

Identifiers

Application: ANDA 70541
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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