Oxcarbazepine

Treats partial-onset seizures. ANDA 78069, held by Breckenridge Pharm. Oxcarbazepine.

As of Nov 15, 2026, ANDA 78069 (Oxcarbazepine), held by Breckenridge Pharm, was first approved by FDA on Jan 11, 2008, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2008
Supplements approved: 11
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 4–16 years Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jan 11, 2008	Original application	Approved	Review

Products

3 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Aug 15, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Aug 28, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Aug 28, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Dec 3, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Dec 3, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jan 20, 2015	Supplement 4Labeling	Approved	None posted
Dec 29, 2011	Supplement 3Labeling	Approved	None posted
Aug 30, 2011	Supplement 2Labeling	Approved	None posted
Jun 29, 2010	Supplement 1Labeling	Approved	None posted
Jan 11, 2008	Original application	Approved	Review

Identifiers

Application: ANDA 78069
Drugs@FDA: Overview at FDA
Company: Breckenridge Pharmaceutical

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