Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 209782, held by Sun Pharm. Deferasirox.

As of Nov 15, 2026, ANDA 209782 (Deferasirox), held by Sun Pharm, was first approved by FDA on Nov 20, 2019, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2019
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox is 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 8 submissions below

Date	Submission	Status	Documents
Nov 20, 2019	Original application	Approved	Letter

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 8 submissions, including labeling and manufacturing supplements


Nov 14, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Nov 14, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Nov 20, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 209782
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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