Megestrol Acetate

Treats advanced carcinoma of the breast or endometrium. ANDA 74621, held by Barr. Megestrol Acetate.

As of Nov 15, 2026, ANDA 74621 (Megestrol Acetate), held by Barr, was first approved by FDA on Nov 30, 1995, with 20 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1995
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Nov 30, 1995	Original application	Approved	None posted

Products

2 strengths and forms


Megestrol Acetate40MG · tablet;oral	Megestrol Acetate	Rx
Megestrol Acetate20MG · tablet;oral	Megestrol Acetate	Rx

All 21 submissions, including labeling and manufacturing supplements


Jul 29, 2010	Supplement 23Manufacturing	Approved	None posted
Mar 18, 2002	Supplement 19Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 18Manufacturing	Approved	None posted
Jan 31, 2002	Supplement 16Manufacturing	Approved	None posted
Jan 31, 2002	Supplement 15Manufacturing	Approved	None posted
Aug 14, 2001	Supplement 17Labeling	Approved	None posted
Jun 5, 2000	Supplement 14Labeling	Approved	None posted
Dec 21, 1999	Supplement 13Manufacturing	Approved	None posted
May 20, 1999	Supplement 12Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 10Manufacturing	Approved	None posted
Nov 25, 1998	Supplement 11Labeling	Approved	None posted
Aug 24, 1998	Supplement 8Labeling	Approved	None posted
Aug 17, 1998	Supplement 9Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 7Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 6Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 5Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 4Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 3Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 2Labeling	Approved	None posted
Aug 16, 1996	Supplement 1Manufacturing	Approved	None posted
Nov 30, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74621
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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