Exemestane

ANDA 77431, held by Hikma. Exemestane.

As of Nov 13, 2026, ANDA 77431 (Exemestane), held by Hikma, was first approved by FDA on Apr 1, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 1, 2011
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 1, 2011	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Exemestane25MG · tablet;oral	Exemestane	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Oct 7, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Jun 15, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jul 6, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jul 6, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 3, 2011	Supplement 1Labeling	Approved	None posted
Apr 1, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 77431
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