Testosterone Enanthate

ANDA 40647, held by Rising. Testosterone Enanthate.

As of Nov 13, 2026, ANDA 40647 (Testosterone Enanthate), held by Rising, was first approved by FDA on Oct 5, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 5, 2009
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 5, 2009	Original application	Approved	Review

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 11, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Sep 23, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 5, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 40647
Drugs@FDA: Overview at FDA
Company: Rising 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