Oxcarbazepine

ANDA 78734, held by Sun Pharm Inds Ltd. Oxcarbazepine.

As of Nov 15, 2026, ANDA 78734 (Oxcarbazepine), held by Sun Pharm Inds Ltd, was first approved by FDA on Jun 26, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 26, 2009
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 26, 2009	Original application	Approved	Review Letter

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Sep 2, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Nov 5, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 5, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 3Labeling	Approved	None posted
Apr 12, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Jun 26, 2009	Original application	Approved	Review Letter

Identifiers

Application: ANDA 78734
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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