Megestrol Acetate

ANDA 75997, held by Hikma. Megestrol Acetate.

As of Nov 15, 2026, ANDA 75997 (Megestrol Acetate), held by Hikma, was first approved by FDA on Feb 15, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2002
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 15, 2002	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Megestrol Acetate40MG/ML · suspension;oral	Megestrol Acetate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 18, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Oct 2, 2007	Supplement 9Labeling	Approved	None posted
May 14, 2007	Supplement 8Labeling	Approved	None posted
Jun 6, 2003	Supplement 2Labeling	Approved	None posted
Feb 15, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 75997
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