Oxcarbazepine

Treats partial-onset seizures. ANDA 215939, held by Annora Pharma. Oxcarbazepine.

As of Nov 15, 2026, ANDA 215939 (Oxcarbazepine), held by Annora Pharma, was first approved by FDA on Jan 11, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2022
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Jan 11, 2022	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


May 28, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jan 11, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 215939
Drugs@FDA: Overview at FDA
Company: Annora Pharma

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