Oxcarbazepine

Treats partial-onset seizures. ANDA 77747, held by Rubicon Research. Oxcarbazepine.

As of Nov 15, 2026, ANDA 77747 (Oxcarbazepine), held by Rubicon Research, was first approved by FDA on Apr 9, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 9, 2008
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxcarbazepine is 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 is 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 10 submissions below

Date	Submission	Status	Documents
Apr 9, 2008	Original application	Approved	Review Other

Products

3 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


May 15, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Aug 4, 2022	Supplement 12Manufacturing	Approved	None posted
Aug 26, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Aug 26, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Dec 19, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Dec 19, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 2013	Supplement 6Labeling	Approved	None posted
Oct 22, 2010	Supplement 4Labeling	Approved	None posted
Apr 29, 2010	Supplement 3Labeling	Approved	None posted
Apr 9, 2008	Original application	Approved	Review Other

Identifiers

Application: ANDA 77747
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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