Epitol

ANDA 73524, held by Teva. Carbamazepine.

As of Nov 15, 2026, ANDA 73524 (Epitol), held by Teva, was first approved by FDA on Jul 29, 1992, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1992
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 29, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Epitol100MG · tablet, chewable;oral	Carbamazepine	Rx

All 29 submissions, including labeling and manufacturing supplements


Jul 22, 2024	Supplement 54Labeling · Standard review	Approved	None posted
Nov 21, 2022	Supplement 53Labeling · Standard review	Approved	None posted
Feb 27, 2020	Supplement 48Labeling · Standard review	Approved	None posted
Feb 27, 2020	Supplement 45Labeling · Standard review	Approved	None posted
Feb 6, 2015	Supplement 43Labeling · Standard review	Approved	None posted
Feb 6, 2015	Supplement 42Labeling · Standard review	Approved	None posted
Mar 10, 2014	Supplement 39Labeling · Standard review	Approved	None posted
Mar 10, 2014	Supplement 38Labeling · Standard review	Approved	None posted
Oct 23, 2012	Supplement 37Labeling · Standard review	Approved	None posted
May 31, 2011	Supplement 36Labeling	Approved	None posted
Jan 21, 2011	Supplement 35Labeling	Approved	None posted
Mar 17, 2010	Supplement 34Labeling	Approved	None posted
Nov 16, 2009	Supplement 31Labeling	Approved	None posted
Mar 26, 2008	Supplement 30Labeling	Approved	None posted
Dec 5, 2002	Supplement 27Labeling	Approved	None posted
May 8, 2002	Supplement 24Labeling	Approved	None posted
Apr 23, 2002	Supplement 25Manufacturing	Approved	None posted
May 1, 2000	Supplement 23Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 22Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 21Manufacturing	Approved	None posted
Aug 13, 1999	Supplement 11Labeling	Approved	None posted
Feb 12, 1999	Supplement 10Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 9Manufacturing	Approved	None posted
Sep 24, 1997	Supplement 8Labeling	Approved	None posted
Feb 4, 1997	Supplement 6Manufacturing	Approved	None posted
Dec 2, 1996	Supplement 5Manufacturing	Approved	None posted
Jul 25, 1996	Supplement 3Manufacturing	Approved	None posted
Feb 9, 1995	Supplement 2Labeling	Approved	None posted
Jul 29, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73524
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