Propylthiouracil

ANDA 80159, held by Impax Labs. Propylthiouracil.

As of Nov 14, 2026, ANDA 80159 (Propylthiouracil), held by Impax Labs, was first approved by FDA on Aug 10, 1973, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 10, 1973
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 10, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propylthiouracil50MG · tablet;oral	Propylthiouracil	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 11, 1991	Supplement 34Labeling	Approved	None posted
Jan 11, 1991	Supplement 35Labeling	Approved	None posted
Dec 14, 1989	Supplement 32Labeling	Approved	None posted
May 2, 1989	Supplement 33Labeling	Approved	None posted
Aug 10, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80159
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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