Testosterone

ANDA 86417, held by Dr Reddys. Testosterone.

As of Nov 14, 2026, ANDA 86417 (Testosterone), held by Dr Reddys, was first approved by FDA on Jul 7, 1983, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 7, 1983
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 7, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone100MG/ML · injectable;injection	Testosterone	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 28Labeling · Standard review	Approved	None posted
Oct 27, 2016	Supplement 26Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 27Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Jun 19, 2014	Supplement 24Labeling · Standard review	Approved	None posted
Feb 19, 1999	Supplement 21Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 19Manufacturing	Approved	None posted
Dec 14, 1998	Supplement 20Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 16Manufacturing	Approved	None posted
Aug 4, 1998	Supplement 18Manufacturing	Approved	None posted
May 7, 1998	Supplement 17Manufacturing	Approved	None posted
Nov 20, 1992	Supplement 15Labeling	Approved	None posted
May 24, 1991	Supplement 14Labeling	Approved	None posted
Nov 2, 1989	Supplement 13Labeling	Approved	None posted
Jan 10, 1989	Supplement 12Manufacturing	Approved	None posted
May 2, 1986	Supplement 5Manufacturing	Approved	None posted
Sep 11, 1984	Supplement 2Manufacturing	Approved	None posted
Jul 7, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 86417
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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