Oxcarbazepine

Treats partial-onset seizures. ANDA 202961, held by Amneal Pharms. Oxcarbazepine.

As of Nov 15, 2026, ANDA 202961 (Oxcarbazepine), held by Amneal Pharms, was first approved by FDA on Sep 17, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 17, 2012
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxcarbazepine oral suspension 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 oral suspension 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 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 8 submissions below

Date	Submission	Status	Documents
Sep 17, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxcarbazepine300MG/5ML · suspension;oral	Oxcarbazepine	Rx

All 8 submissions, including labeling and manufacturing supplements


Feb 7, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Mar 1, 2023	Supplement 16Manufacturing	Approved	None posted
Nov 1, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Nov 1, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Nov 1, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Sep 17, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202961
Drugs@FDA: Overview at FDA
Company: Amneal 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