Megestrol Acetate

ANDA 204688, held by Chartwell. Megestrol Acetate.

As of Nov 15, 2026, ANDA 204688 (Megestrol Acetate), held by Chartwell, was first approved by FDA on Dec 1, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 1, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 1, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Megestrol Acetate125MG/ML · suspension;oral	Megestrol Acetate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 24, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Dec 1, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204688
Drugs@FDA: Overview at FDA
Company: Chartwell

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