Testosterone

ANDA 209181, held by Apotex. Testosterone.

As of Nov 14, 2026, ANDA 209181 (Testosterone), held by Apotex, was first approved by FDA on Nov 25, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 25, 2020
Review: Standard
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
Nov 25, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone30MG/1.5ML ACTUATION · solution, metered;transdermal	Testosterone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Nov 25, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 209181
Drugs@FDA: Overview at FDA
Company: Apotex

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