Propylthiouracil

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 208867, held by Macleods Pharms. Propylthiouracil.

As of Nov 14, 2026, ANDA 208867 (Propylthiouracil), held by Macleods Pharms, was first approved by FDA on May 10, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: May 10, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Propylthiouracil are 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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 10, 2023	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 26, 2024	Supplement 1Labeling · Standard review	Approved	None posted
May 10, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 208867
Drugs@FDA: Overview at FDA
Company: Macleods 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