Methyltestosterone

ANDA 87092, held by Lannett. Methyltestosterone.

As of Nov 14, 2026, ANDA 87092 (Methyltestosterone), held by Lannett, was first approved by FDA on Nov 5, 1982, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1982
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
Nov 5, 1982	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyltestosterone10MG · tablet;oral	Methyltestosterone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 5Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jun 19, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Jan 5, 1988	Supplement 1Labeling	Approved	None posted
Nov 5, 1982	Original application	Approved	Review

Identifiers

Application: ANDA 87092
Drugs@FDA: Overview at FDA
Company: Lannett Company

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