Methyltestosterone

ANDA 80767, held by Impax Labs. Methyltestosterone.

As of Nov 14, 2026, ANDA 80767 (Methyltestosterone), held by Impax Labs, was first approved by FDA on Oct 17, 1974, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1974
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 17, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyltestosterone10MG · tablet;oral	Methyltestosterone	Rx

All 17 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 91Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 82Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 78Labeling · Standard review	Approved	None posted
Jun 19, 2014	Supplement 77Labeling · Standard review	Approved	None posted
Nov 4, 2002	Supplement 67Labeling	Approved	None posted
Mar 8, 2002	Supplement 66Labeling	Approved	None posted
Mar 8, 2002	Supplement 65Manufacturing	Approved	None posted
Mar 10, 2000	Supplement 64Labeling	Approved	None posted
Oct 29, 1997	Supplement 63Labeling	Approved	None posted
Oct 9, 1991	Supplement 62Labeling	Approved	None posted
Jul 5, 1991	Supplement 61Labeling	Approved	None posted
Jan 19, 1990	Supplement 60Labeling	Approved	None posted
Jul 20, 1989	Supplement 59Labeling	Approved	None posted
Jul 20, 1989	Supplement 58Labeling	Approved	None posted
Oct 31, 1988	Supplement 57Labeling	Approved	None posted
Jul 6, 1988	Supplement 55Labeling	Approved	None posted
Oct 17, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80767
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