Virilon

ANDA 87750, held by Chartwell. Methyltestosterone.

As of Nov 14, 2026, ANDA 87750 (Virilon), held by Chartwell, was first approved by FDA on Nov 24, 1982, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 24, 1982
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Nov 24, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Virilon10MG · capsule;oral	Methyltestosterone	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jul 15, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Jan 26, 2017	Supplement 16Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Jun 19, 2014	Supplement 14Labeling · Standard review	Approved	None posted
Mar 24, 1993	Supplement 8Labeling	Approved	None posted
May 7, 1992	Supplement 7Labeling	Approved	None posted
Mar 4, 1992	Supplement 6Labeling	Approved	None posted
Apr 10, 1989	Supplement 5Labeling	Approved	None posted
Mar 6, 1989	Supplement 4Labeling	Approved	None posted
Jul 1, 1988	Supplement 3Labeling	Approved	None posted
Nov 24, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87750
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