Anastrozole

ANDA 200654, held by Apotex Inc. Anastrozole.

As of Nov 15, 2026, ANDA 200654 (Anastrozole), held by Apotex Inc, was first approved by FDA on May 11, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: May 11, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 11, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Anastrozole1MG · tablet;oral	Anastrozole	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 8, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jul 8, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jan 12, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Jan 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
May 11, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200654
Drugs@FDA: Overview at FDA
Company: Apotex

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