Methyltestosterone

ANDA 84287, held by Impax Labs. Methyltestosterone.

As of Nov 14, 2026, ANDA 84287 (Methyltestosterone), held by Impax Labs, was first approved by FDA on Jul 16, 1974, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 16, 1974
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 16, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyltestosterone10MG · tablet;buccal, sublingual	Methyltestosterone	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Oct 29, 1997	Supplement 66Labeling	Approved	None posted
Oct 9, 1991	Supplement 65Labeling	Approved	None posted
Jul 5, 1991	Supplement 64Labeling	Approved	None posted
Jan 19, 1990	Supplement 63Labeling	Approved	None posted
Nov 28, 1989	Supplement 62Labeling	Approved	None posted
Jul 20, 1989	Supplement 61Labeling	Approved	None posted
May 11, 1989	Supplement 60Labeling	Approved	None posted
Oct 31, 1988	Supplement 59Labeling	Approved	None posted
Jul 6, 1988	Supplement 58Labeling	Approved	None posted
Jul 16, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84287
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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