Propylthiouracil

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. ANDA 80172, held by Actavis Elizabeth. Propylthiouracil.

As of Nov 14, 2026, ANDA 80172 (Propylthiouracil), held by Actavis Elizabeth, was first approved by FDA on Jan 9, 1973, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1973
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Propylthiouracil tablets 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 23 submissions below

Date	Submission	Status	Documents
Jan 9, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	Rx

All 23 submissions, including labeling and manufacturing supplements


Dec 6, 2019	Supplement 60Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 57Labeling · Standard review	Approved	None posted
Oct 13, 2011	Supplement 50REMS	Approved	None posted
Oct 11, 2011	Supplement 49Labeling	Approved	None posted
Jan 21, 2011	Supplement 48Labeling	Approved	None posted
Dec 15, 2010	Supplement 46REMS	Approved	None posted
Mar 25, 2002	Supplement 33Labeling	Approved	None posted
Nov 2, 2001	Supplement 32Manufacturing	Approved	None posted
Dec 11, 2000	Supplement 31Manufacturing	Approved	None posted
Oct 29, 1999	Supplement 30Manufacturing	Approved	None posted
Jan 18, 1996	Supplement 29Manufacturing	Approved	None posted
Apr 7, 1994	Supplement 27Manufacturing	Approved	None posted
Apr 7, 1994	Supplement 26Manufacturing	Approved	None posted
Jan 23, 1991	Supplement 25Labeling	Approved	None posted
Jul 21, 1988	Supplement 23Manufacturing	Approved	None posted
May 23, 1988	Supplement 24Labeling	Approved	None posted
Jul 16, 1987	Supplement 22Manufacturing	Approved	None posted
Jan 23, 1987	Supplement 21Manufacturing	Approved	None posted
Feb 20, 1985	Supplement 18Manufacturing	Approved	None posted
Feb 20, 1985	Supplement 17Manufacturing	Approved	None posted
Jul 26, 1983	Supplement 14Manufacturing	Approved	None posted
Jul 26, 1983	Supplement 13Manufacturing	Approved	None posted
Jan 9, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80172
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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