Testosterone Enanthate

ANDA 40575, held by Nexus. Testosterone Enanthate.

As of Nov 13, 2026, ANDA 40575 (Testosterone Enanthate), held by Nexus, was first approved by FDA on Jun 14, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2006
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 14, 2006	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Testosterone Enanthate200MG/ML · injectable;injection	Testosterone Enanthate	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 11, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Oct 30, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Sep 2, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Jan 6, 2009	Supplement 2Labeling	Approved	None posted
Jun 14, 2006	Original application	Approved	Review

Identifiers

Application: ANDA 40575
Drugs@FDA: Overview at FDA
Company: Nexus 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