← FDA DRUG APPROVALS

FDA ANDA · ANDA080343

PREDNISONE

Sponsor: WHITEWORTH TOWN PLSN

APPLICATION
ANDA080343
TYPE
ANDA
ORIGINAL APPROVAL
1973-06-20
LATEST ACTION
1986-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISONEDiscontinued
PREDNISONE 5MG · TABLET · ORAL

Approval history

1986-01-15Manufacturing (CMC) · Supplement 15AP
1986-01-15Manufacturing (CMC) · Supplement 13AP
1973-06-20OriginalAP
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 →