Methimazole

For Graves' disease with hyperthyroidism or toxic multinodular goiter. ANDA 40734, held by Heritage Pharma. Methimazole.

As of Nov 13, 2026, ANDA 40734 (Methimazole), held by Heritage Pharma, was first approved by FDA on Dec 14, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2007
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Methimazole tablets are indicated:

In patients with Graves' disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option.
To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 14, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Methimazole5MG · tablet;oral	Methimazole	Rx
Methimazole10MG · tablet;oral	Methimazole	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 26, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Jan 18, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Dec 14, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40734
Drugs@FDA: Overview at FDA
Company: Heritage 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