Methimazole

ANDA 40619, held by Discovery Therap. Methimazole.

As of Nov 13, 2026, ANDA 40619 (Methimazole), held by Discovery Therap, was first approved by FDA on Jul 12, 2005, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2005
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 12, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methimazole15MG · tablet;oral	Methimazole	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 18, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jul 12, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 40619
Drugs@FDA: Overview at FDA
Company: Discovery Therapeutics

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