Deferasirox

ANDA 208697, held by Actavis Elizabeth. Deferasirox.

As of Nov 15, 2026, ANDA 208697 (Deferasirox), held by Actavis Elizabeth, was first approved by FDA on Dec 13, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 13, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 13, 2019	Original application	Approved	Letter

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 7, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Nov 7, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Dec 13, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 208697
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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