For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 40411, held by Chartwell Rx. Methimazole.
As of Nov 13, 2026, ANDA 40411 (Methimazole), held by Chartwell Rx, was first approved by FDA on Mar 27, 2001, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methimazole tablets, USP 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2001 | Original application | Approved |
| Methimazole5MG · tablet;oral | Methimazole | Rx |
| Methimazole10MG · tablet;oral | Methimazole | Rx |
| Jul 21, 2025 | Supplement 29Labeling · Standard review | Approved | None posted |
| Jan 18, 2019 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jan 15, 2016 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jul 11, 2012 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 22, 2011 | Supplement 13Labeling | Approved | None posted |
| Mar 28, 2011 | Supplement 12Labeling | Approved | None posted |
| Jan 8, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jul 26, 2001 | Supplement 1Labeling | Approved | None posted |
| Mar 27, 2001 | Original application | Approved |
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
