Deferasirox

ANDA 203560, held by Actavis Elizabeth. Deferasirox.

As of Nov 15, 2026, ANDA 203560 (Deferasirox), held by Actavis Elizabeth, was first approved by FDA on Jan 26, 2016, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2016
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jan 26, 2016	Original application	Approved	Letter Label

Products

3 strengths and forms


Deferasirox125MG · tablet, for suspension;oral	Deferasirox	Rx
Deferasirox250MG · tablet, for suspension;oral	Deferasirox	Rx
Deferasirox500MG · tablet, for suspension;oral	Deferasirox	Rx

All 7 submissions, including labeling and manufacturing supplements


Oct 21, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Oct 21, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Jan 26, 2016	Original application	Approved	Letter Label

Identifiers

Application: ANDA 203560
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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