Android 5

ANDA 87222, held by Valeant Pharm Intl. Methyltestosterone.

As of Nov 14, 2026, ANDA 87222 (Android 5), held by Valeant Pharm Intl, was first approved by FDA on Feb 9, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 9, 1981
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 9, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Android 55MG · tablet;buccal	Methyltestosterone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Dec 18, 1990	Supplement 5Labeling	Approved	None posted
Feb 9, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87222
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

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