Deferasirox

Treats chronic iron overload due to blood transfusions. ANDA 214341, held by Annora Pharma. Deferasirox.

As of Nov 15, 2026, ANDA 214341 (Deferasirox), held by Annora Pharma, was first approved by FDA on May 14, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: May 14, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferasirox tablets 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 2 submissions below

Date	Submission	Status	Documents
May 14, 2021	Original application	Approved	None posted

Products

3 strengths and forms


Deferasirox90MG · tablet;oral	Deferasirox	Rx
Deferasirox180MG · tablet;oral	Deferasirox	Rx
Deferasirox360MG · tablet;oral	Deferasirox	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 18, 2024	Supplement 1Labeling · Standard review	Approved	None posted
May 14, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214341
Drugs@FDA: Overview at FDA
Company: Annora 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