Megestrol Acetate

ANDA 74458, held by Hikma. Megestrol Acetate.

As of Nov 15, 2026, ANDA 74458 (Megestrol Acetate), held by Hikma, was first approved by FDA on Sep 29, 1995, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1995
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 29, 1995	Original application	Approved	None posted

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Oct 2, 2007	Supplement 6Labeling	Approved	None posted
May 30, 2007	Supplement 5Labeling	Approved	None posted
May 20, 2003	Supplement 4Labeling	Approved	None posted
Dec 12, 2001	Supplement 3Labeling	Approved	None posted
Dec 3, 1998	Supplement 2Labeling	Approved	None posted
Aug 24, 1998	Supplement 1Labeling	Approved	None posted
Sep 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74458
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