Anastrozole

As of Nov 15, 2026, ANDA 78485 (Anastrozole), held by Hikma, was first approved by FDA on Jun 28, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 28, 2010
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 28, 2010	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Anastrozole1MG · tablet;oral	Anastrozole	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 24, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Feb 21, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Nov 14, 2011	Supplement 2Labeling	Approved	None posted
Jun 28, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 78485
Drugs@FDA: Overview at FDA
Company: Hikma

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