Carbamazepine

ANDA 78592, held by Teva Pharms. Carbamazepine.

As of Nov 15, 2026, ANDA 78592 (Carbamazepine), held by Teva Pharms, was first approved by FDA on Sep 20, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2012
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 20, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Carbamazepine100MG · capsule, extended release;oral	Carbamazepine	Rx
Carbamazepine200MG · capsule, extended release;oral	Carbamazepine	Rx
Carbamazepine300MG · capsule, extended release;oral	Carbamazepine	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 15, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 20, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 78592
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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