Deferasirox

ANDA 214180, held by Teva Pharms USA. Deferasirox.

As of Nov 15, 2026, ANDA 214180 (Deferasirox), held by Teva Pharms USA, was first approved by FDA on Nov 19, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 19, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 19, 2021	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 20, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 7, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Apr 7, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Nov 19, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 214180
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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