← FDA DRUG APPROVALS

FDA ANDA · ANDA080745

ARISTOCORT A

Sponsor: ASTELLAS

APPLICATION
ANDA080745
TYPE
ANDA
ORIGINAL APPROVAL
1972-04-28
LATEST ACTION
1989-10-13
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

ARISTOCORT A · ReferenceDiscontinued
TRIAMCINOLONE ACETONIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
ARISTOCORT · ReferenceDiscontinued
TRIAMCINOLONE ACETONIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

1989-10-13Manufacturing (CMC) · Supplement 26AP
1989-10-13Manufacturing (CMC) · Supplement 24AP
1989-10-13Labeling · Supplement 25AP
1983-12-28Manufacturing (CMC) · Supplement 22AP
1972-04-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →