Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 209433, held by Glenmark Speclt. Deferasirox.

As of Nov 15, 2026, ANDA 209433 (Deferasirox), held by Glenmark Speclt, was first approved by FDA on Jan 3, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

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 3, 2020	Original application	Approved	None posted

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 3 submissions, including labeling and manufacturing supplements


May 19, 2023	Supplement 1Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jan 3, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 209433
Drugs@FDA: Overview at FDA
Company: Glenmark Specialty

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