Propylthiouracil

For Graves’ disease with hyperthyroidism or toxic multinodular goiter. Sold as Propylthiouracil. Every FDA application for this active ingredient: 2 branded and 14 generic.

As of Nov 14, 2026, FDA lists 16 applications for Propylthiouracil (sold as Propylthiouracil), first approved Jul 28, 1947, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 28, 1947
Applications: 16
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Propylthiouracil	Part D	$1.9M	-11%	8,961

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PROPYLTHIOURACIL 50 MG TABLET: $0.270 per unitGeneric · -7% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Somesthesia in Cancer Patients: Variability and Influence on Eating ExperienceDigestive Cancers, Breast Cancer · Hospices Civils de Lyon	—	Not yet recruiting	Jan 31, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 28, 1947	PropylthiouracilNDA 6188	Ph Health	17	Marketed
Jul 29, 1947	PropylthiouracilNDA 6213	Lilly	10	Discontinued
Jul 24, 1970	PropylthiouracilANDA 80016	Chartwell Molecular	2	Discontinued
Jul 23, 1971	PropylthiouracilANDA 80154	Quagen	21	Marketed
Jan 9, 1973	PropylthiouracilANDA 80172	Actavis Elizabeth	22	Marketed
Aug 10, 1973	PropylthiouracilANDA 80159	Impax Labs	4	Discontinued
May 6, 1974	PropylthiouracilANDA 83982	Sun Pharm Industries	16	Discontinued
Dec 19, 1974	PropylthiouracilANDA 80285	Anabolic	0	Discontinued
Mar 3, 1977	PropylthiouracilANDA 85201	Watson Labs	0	Discontinued
May 10, 2023	PropylthiouracilANDA 208867	Macleods Pharms	1	Marketed
—	PropylthiouracilANDA 80015	Halsey	0	Discontinued
—	PropylthiouracilANDA 80215	Ani Pharms	0	Discontinued
—	PropylthiouracilANDA 80840	Tablicaps	0	Discontinued
—	PropylthiouracilANDA 80932	Watson Labs	0	Discontinued
—	PropylthiouracilANDA 84075	Abbott	0	Discontinued
—	PropylthiouracilANDA 84543	Chartwell Rx	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA