Propylthiouracil

NDA 6213, held by Lilly. Propylthiouracil.

As of Nov 14, 2026, NDA 6213 (Propylthiouracil), held by Lilly, was first approved by FDA on Jul 29, 1947, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1947
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 29, 1947	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 5, 1990	Supplement 17Labeling	Approved	None posted
Jan 18, 1990	Supplement 18Labeling	Approved	None posted
Aug 15, 1989	Supplement 16Labeling	Approved	None posted
Aug 15, 1989	Supplement 15Labeling	Approved	None posted
Jul 6, 1987	Supplement 14Labeling	Approved	None posted
Aug 8, 1986	Supplement 13Labeling	Approved	None posted
May 7, 1986	Supplement 12Labeling	Approved	None posted
Jan 7, 1986	Supplement 11Labeling	Approved	None posted
Jun 2, 1982	Supplement 10Labeling	Approved	None posted
May 13, 1976	Supplement 6Labeling	Approved	None posted
Jul 29, 1947	Original application	Approved	None posted

Identifiers

Application: NDA 6213
Drugs@FDA: Overview at FDA
Company: Lilly

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