Exemestane

ANDA 206421, held by Amneal Pharms. Exemestane.

As of Nov 13, 2026, ANDA 206421 (Exemestane), held by Amneal Pharms, was first approved by FDA on Dec 28, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 28, 2018
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 28, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Exemestane25MG · tablet;oral	Exemestane	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 1, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Mar 28, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Dec 28, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 206421
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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