Deferasirox

ANDA 211641, held by Sun Pharm. Deferasirox.

As of Nov 15, 2026, ANDA 211641 (Deferasirox), held by Sun Pharm, was first approved by FDA on Jun 15, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Jun 15, 2020	Original application	Approved	Letter
Jan 2, 2020	Original application	Approved	Letter

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Dec 16, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jun 15, 2020	Original application	Approved	Letter
May 14, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jan 2, 2020	Original application	Approved	Letter

Identifiers

Application: ANDA 211641
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