Methimazole

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 202068, held by Rising. Methimazole.

As of Nov 13, 2026, ANDA 202068 (Methimazole), held by Rising, was first approved by FDA on Mar 7, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2012
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
Mar 7, 2012	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


Oct 20, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jan 23, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Mar 7, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202068
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