Oxcarbazepine

ANDA 90239, held by Jubilant Cadista. Oxcarbazepine.

As of Nov 15, 2026, ANDA 90239 (Oxcarbazepine), held by Jubilant Cadista, was first approved by FDA on Jan 25, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2010
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 25, 2010	Original application	Approved	None posted

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jan 20, 2015	Supplement 1Labeling	Approved	None posted
Jan 20, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jan 25, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90239
Drugs@FDA: Overview at FDA
Company: Jubilant Cadista 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