Oxcarbazepine

Treats partial-onset seizures. ANDA 77802, held by Glenmark Pharms Ltd. Oxcarbazepine.

As of Nov 15, 2026, ANDA 77802 (Oxcarbazepine), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 9, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 9, 2007
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are indicated for:

Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 9, 2007	Original application	Approved	Letter Label

Products

3 strengths and forms


Oxcarbazepine150MG · tablet;oral	Oxcarbazepine	Rx
Oxcarbazepine300MG · tablet;oral	Oxcarbazepine	Rx
Oxcarbazepine600MG · tablet;oral	Oxcarbazepine	Rx

All 11 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 29Labeling · Standard review	Approved	None posted
Sep 17, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Aug 25, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jan 19, 2012	Supplement 5REMS	Approved	None posted
Dec 28, 2011	Supplement 4Labeling	Approved	None posted
Jun 29, 2010	Supplement 2Labeling	Approved	None posted
Oct 9, 2007	Original application	Approved	Letter Label

Identifiers

Application: ANDA 77802
Drugs@FDA: Overview at FDA
Company: Glenmark 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