Testopel

ANDA 80911, held by Endo Operations. Testosterone.

As of Nov 14, 2026, ANDA 80911 (Testopel), held by Endo Operations, was first approved by FDA on Jul 13, 1972, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1972
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy. b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 13, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testopel75MG · pellet;implantation	Testosterone	Rx

All 15 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 23Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Aug 1, 2016	Supplement 20Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 19Labeling · Standard review	Approved	None posted
Nov 17, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Apr 8, 1996	Supplement 13Manufacturing	Approved	None posted
Feb 24, 1995	Supplement 10Manufacturing	Approved	None posted
Aug 15, 1994	Supplement 11Manufacturing	Approved	Review
Dec 21, 1992	Supplement 9Labeling	Approved	None posted
May 8, 1992	Supplement 8Labeling	Approved	None posted
Sep 10, 1986	Supplement 6Manufacturing	Approved	None posted
Sep 10, 1986	Supplement 5Manufacturing	Approved	None posted
Aug 3, 1982	Supplement 4Manufacturing	Approved	None posted
Jul 13, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80911
Drugs@FDA: Overview at FDA
Company: Endo Operations

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