Android 10

ANDA 86450, held by Valeant Pharms North. Methyltestosterone.

As of Nov 14, 2026, ANDA 86450 (Android 10), held by Valeant Pharms North, was first approved by FDA on Feb 9, 1981, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1981
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
Feb 9, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Android 1010MG · tablet;oral	Methyltestosterone	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Oct 25, 2016	Supplement 14Labeling · Standard review	Approved	None posted
May 11, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Jun 19, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Oct 16, 1996	Supplement 11Manufacturing	Approved	None posted
Oct 16, 1996	Supplement 10Manufacturing	Approved	None posted
Oct 16, 1996	Supplement 9Manufacturing	Approved	None posted
Oct 16, 1996	Supplement 8Labeling	Approved	None posted
Oct 16, 1996	Supplement 7Manufacturing	Approved	None posted
Oct 16, 1996	Supplement 6Manufacturing	Approved	None posted
Dec 18, 1990	Supplement 5Labeling	Approved	None posted
Jun 23, 1986	Supplement 3Manufacturing	Approved	None posted
Jun 11, 1985	Supplement 2Manufacturing	Approved	None posted
Feb 9, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86450
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals North America

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