Testosterone

ANDA 86419, held by Watson Labs. Testosterone.

As of Nov 14, 2026, ANDA 86419 (Testosterone), held by Watson Labs, was first approved by FDA on Aug 23, 1983, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 23, 1983
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 23, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone50MG/ML · injectable;injection	Testosterone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


May 8, 1992	Supplement 15Labeling	Approved	None posted
May 24, 1991	Supplement 14Labeling	Approved	None posted
Nov 16, 1989	Supplement 13Labeling	Approved	None posted
Aug 23, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 86419
Drugs@FDA: Overview at FDA
Company: Watson 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