For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 80016, held by Chartwell Molecular. Propylthiouracil.
As of Nov 14, 2026, ANDA 80016 (Propylthiouracil), held by Chartwell Molecular, was first approved by FDA on Jul 24, 1970, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Propylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and 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 in patients who are intolerant of methimazole.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 1970 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propylthiouracil50MG · tablet;oral | Propylthiouracil | Discontinued |
| Aug 31, 1990 | Supplement 9Labeling | Approved | None posted |
| Mar 28, 1990 | Supplement 8Labeling | Approved | None posted |
| Jul 24, 1970 | Original application | Approved | None posted |
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
