Propylthiouracil

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 80154, held by Quagen. Propylthiouracil.

As of Nov 14, 2026, ANDA 80154 (Propylthiouracil), held by Quagen, was first approved by FDA on Jul 23, 1971, with 21 approved supplements and 0 published complete response letters.

First approved: Jul 23, 1971
Supplements approved: 21
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 22 submissions below

Date	Submission	Status	Documents
Jul 23, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	Rx

All 22 submissions, including labeling and manufacturing supplements


Mar 18, 2021	Supplement 44Manufacturing	Approved	None posted
Aug 26, 2020	Supplement 43Labeling · Standard review	Approved	None posted
Nov 30, 2016	Supplement 42Labeling · Standard review	Approved	None posted
Nov 30, 2016	Supplement 39Labeling · Standard review	Approved	None posted
Aug 22, 2011	Supplement 37Labeling	Approved	None posted
Dec 29, 2010	Supplement 36Labeling	Approved	None posted
Nov 21, 2002	Supplement 32Labeling	Approved	None posted
Mar 12, 2002	Supplement 30Manufacturing	Approved	None posted
Jun 28, 2001	Supplement 29Manufacturing	Approved	None posted
Mar 12, 2001	Supplement 28Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 26Labeling	Approved	None posted
Feb 17, 1999	Supplement 25Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 27Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 22Labeling	Approved	None posted
Jan 31, 1995	Supplement 20Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 19Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 18Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 17Manufacturing	Approved	None posted
Nov 19, 1985	Supplement 14Manufacturing	Approved	None posted
Nov 19, 1984	Supplement 13Manufacturing	Approved	None posted
Jan 26, 1983	Supplement 7Manufacturing	Approved	None posted
Jul 23, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80154
Drugs@FDA: Overview at FDA
Company: Quagen 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