Megestrol Acetate

Treats advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or…. ANDA 72422, held by Strides Pharma Intl. Megestrol Acetate.

As of Nov 15, 2026, ANDA 72422 (Megestrol Acetate), held by Strides Pharma Intl, was first approved by FDA on Aug 8, 1988, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 8, 1988
Supplements approved: 18
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 (ie, 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 19 submissions below

Date	Submission	Status	Documents
Aug 8, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Megestrol Acetate20MG · tablet;oral	Megestrol Acetate	Rx

All 19 submissions, including labeling and manufacturing supplements


Aug 6, 2004	Supplement 18Labeling	Approved	None posted
Aug 29, 2003	Supplement 17Labeling	Approved	None posted
Dec 12, 2001	Supplement 16Labeling	Approved	None posted
Oct 11, 2001	Supplement 14Labeling	Approved	None posted
Oct 11, 2001	Supplement 15Manufacturing	Approved	None posted
Oct 13, 2000	Supplement 13Labeling	Approved	None posted
Jun 27, 2000	Supplement 12Labeling	Approved	None posted
Oct 29, 1999	Supplement 10Manufacturing	Approved	None posted
Oct 29, 1999	Supplement 11Labeling	Approved	None posted
May 19, 1999	Supplement 9Labeling	Approved	None posted
Feb 19, 1999	Supplement 8Labeling	Approved	None posted
Aug 31, 1998	Supplement 7Labeling	Approved	None posted
Nov 26, 1997	Supplement 5Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 6Manufacturing	Approved	None posted
Nov 20, 1995	Supplement 4Manufacturing	Approved	None posted
Mar 4, 1992	Supplement 3Labeling	Approved	None posted
Jul 2, 1991	Supplement 2Labeling	Approved	None posted
Aug 1, 1989	Supplement 1Labeling	Approved	None posted
Aug 8, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72422
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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