For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 209827, held by Macleods Pharms. Methimazole.
As of Nov 13, 2026, ANDA 209827 (Methimazole), held by Macleods Pharms, was first approved by FDA on May 24, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Methimazole is 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 |
|---|---|---|---|
| May 24, 2023 | Original application | Approved | None posted |
| Methimazole5MG · tablet;oral | Methimazole | Rx |
| Methimazole10MG · tablet;oral | Methimazole | Rx |
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
