Methyltestosterone

ANDA 84312, held by Kv Pharm. Methyltestosterone.

As of Nov 14, 2026, ANDA 84312 (Methyltestosterone), held by Kv Pharm, was first approved by FDA on Oct 8, 1976, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 8, 1976
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 8, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyltestosterone10MG · tablet;oral	Methyltestosterone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 29, 1982	Supplement 10Manufacturing	Approved	None posted
Apr 29, 1982	Supplement 11Manufacturing	Approved	None posted
Apr 29, 1982	Supplement 13Manufacturing	Approved	None posted
Oct 8, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84312
Drugs@FDA: Overview at FDA
Company: KV Pharmaceutical

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