← FDA DRUG APPROVALS

FDA ANDA · ANDA080159

PROPYLTHIOURACIL

Sponsor: IMPAX LABS

APPLICATION
ANDA080159
TYPE
ANDA
ORIGINAL APPROVAL
1973-08-10
LATEST ACTION
1991-01-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPYLTHIOURACILDiscontinued
PROPYLTHIOURACIL 50MG · TABLET · ORAL

Approval history

1991-01-11Labeling · Supplement 35AP
1991-01-11Labeling · Supplement 34AP
1989-12-14Labeling · Supplement 32AP
1989-05-02Labeling · Supplement 33AP
1973-08-10OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →