Propylthiouracil

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. NDA 6188, held by Ph Health. Propylthiouracil.

As of Nov 14, 2026, NDA 6188 (Propylthiouracil), held by Ph Health, was first approved by FDA on Jul 28, 1947, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1947
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 28, 1947	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 19, 2018	Supplement 26Labeling	Approved	Label Medication Guide
Jan 15, 2016	Supplement 25Labeling · Standard review	Approved	Label Letter
Feb 10, 2015	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 19, 2013	Supplement 23Manufacturing	Approved	None posted
Jul 27, 2011	Supplement 21Labeling	Approved	Letter Label
Jul 27, 2011	Supplement 22REMS	Approved	Letter Label
Apr 1, 2010	Supplement 20Labeling	Approved	Letter Label
Oct 1, 2001	Supplement 18Labeling · Standard review	Approved	Label
Oct 1, 2001	Supplement 19Labeling · Standard review	Approved	Label
Mar 11, 1999	Supplement 17Manufacturing	Approved	None posted
Apr 26, 1996	Supplement 16Manufacturing	Approved	None posted
Apr 1, 1996	Supplement 15Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 14Labeling	Approved	None posted
Dec 4, 1987	Supplement 11Manufacturing	Approved	None posted
Jan 15, 1986	Supplement 10Labeling	Approved	None posted
Oct 31, 1980	Supplement 5Manufacturing	Approved	None posted
Oct 31, 1980	Supplement 6Manufacturing	Approved	None posted
Jul 28, 1947	Original application	Approved	None posted

Identifiers

Application: NDA 6188
Drugs@FDA: Overview at FDA
Company: PH Health

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