Testosterone Enanthate

ANDA 85598, held by Watson Pharms Inc. Testosterone Enanthate.

As of Nov 13, 2026, ANDA 85598 (Testosterone Enanthate), held by Watson Pharms Inc, was first approved by FDA on Dec 10, 1980, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1980
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 10, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone Enanthate200MG/ML · injectable;injection	Testosterone Enanthate	Discontinued

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 11, 2025	Supplement 55Labeling · Standard review	Approved	None posted
Nov 2, 2020	Supplement 54Labeling · Standard review	Approved	None posted
Sep 18, 2015	Supplement 53Labeling · Standard review	Approved	None posted
Apr 19, 1999	Supplement 40Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 38Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 37Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 36Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 35Manufacturing	Approved	None posted
Jun 30, 1994	Supplement 28Labeling	Approved	None posted
Jun 30, 1994	Supplement 29Manufacturing	Approved	None posted
Mar 30, 1993	Supplement 34Labeling	Approved	None posted
Dec 11, 1991	Supplement 33Labeling	Approved	None posted
May 15, 1991	Supplement 32Labeling	Approved	None posted
Oct 12, 1990	Supplement 31Labeling	Approved	None posted
Mar 12, 1990	Supplement 30Labeling	Approved	None posted
Apr 30, 1986	Supplement 23Manufacturing	Approved	None posted
Jan 28, 1985	Supplement 22Manufacturing	Approved	None posted
May 19, 1982	Supplement 19Manufacturing	Approved	None posted
Dec 10, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 85598
Drugs@FDA: Overview at FDA
Company: Watson Pharms Inc

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