Megace Es

NDA 21778, held by Endo Operations. Megestrol Acetate.

As of Nov 15, 2026, NDA 21778 (Megace Es), held by Endo Operations, was first approved by FDA on Jul 5, 2005, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 5, 2005
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 5, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Megace Es125MG/ML · suspension;oral	Megestrol Acetate	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Dec 18, 2018	Supplement 24Labeling · Standard review	Approved	Letter Label
Nov 5, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 16, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 16, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 18, 2014	Supplement 18Labeling · Standard review	Approved	Letter Label
Jul 31, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 17, 2014	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 14, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
May 14, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Jan 25, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 21, 2010	Supplement 8Labeling · Standard review	Approved	Label Letter
Aug 12, 2008	Supplement 7Labeling · Standard review	Approved	Letter
Mar 19, 2007	Supplement 3Manufacturing · Standard review	Approved	Label Letter
Mar 19, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 5, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21778
Drugs@FDA: Overview at FDA
Company: Endo Operations

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