Testred

ANDA 83976, held by Bausch. Methyltestosterone.

As of Nov 14, 2026, ANDA 83976 (Testred), held by Bausch, was first approved by FDA on Dec 3, 1973, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1973
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 3, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testred10MG · capsule;oral	Methyltestosterone	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 35Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 34Labeling · Standard review	Approved	Label
May 11, 2015	Supplement 32Labeling · Standard review	Approved	Label
Jun 19, 2014	Supplement 31Labeling · Standard review	Approved	Label
Nov 27, 2002	Supplement 27Labeling	Approved	None posted
Aug 18, 1998	Supplement 26Manufacturing	Approved	None posted
Aug 25, 1997	Supplement 25Manufacturing	Approved	None posted
Aug 25, 1997	Supplement 24Manufacturing	Approved	None posted
Aug 8, 1994	Supplement 23Labeling	Approved	None posted
Nov 3, 1992	Supplement 22Labeling	Approved	None posted
May 29, 1992	Supplement 21Labeling	Approved	None posted
May 25, 1989	Supplement 20Labeling	Approved	None posted
Mar 8, 1983	Supplement 18Manufacturing	Approved	None posted
Dec 3, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83976
Drugs@FDA: Overview at FDA
Company: Bausch Health

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