Testosterone

ANDA 209836, held by Twi Pharms. Testosterone.

As of Nov 14, 2026, ANDA 209836 (Testosterone), held by Twi Pharms, was first approved by FDA on Sep 3, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 3, 2021
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
Sep 3, 2021	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 9Labeling · Standard review	Approved	None posted
Sep 3, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 209836
Drugs@FDA: Overview at FDA
Company: TWi Pharmaceuticals

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