For Graves' disease with hyperthyroidism or toxic multinodular goiter. ANDA 40350, held by Mylan. Methimazole.
As of Nov 13, 2026, ANDA 40350 (Methimazole), held by Mylan, was first approved by FDA on Mar 29, 2000, with 10 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2000 | Original application | Approved |
| Methimazole5MG · tablet;oral | Methimazole | Rx |
| Methimazole10MG · tablet;oral | Methimazole | Rx |
| Methimazole20MG · tablet;oral | Methimazole | Discontinued |
| Oct 20, 2021 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jan 18, 2019 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jan 15, 2016 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jul 11, 2012 | Supplement 16Labeling | Approved | |
| Sep 28, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Jul 10, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Jun 7, 2001 | Supplement 1Manufacturing | Approved | |
| Jun 7, 2001 | Supplement 2Manufacturing | Approved | |
| Jun 7, 2001 | Supplement 3Manufacturing | Approved | |
| Jun 7, 2001 | Supplement 4Labeling | Approved | None posted |
| Mar 29, 2000 | 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
