← FDA DRUG APPROVALS

FDA ANDA · ANDA080780

PREDNISOLONE

Sponsor: IMPAX LABS

APPLICATION
ANDA080780
TYPE
ANDA
ORIGINAL APPROVAL
1973-07-13
LATEST ACTION
2001-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISOLONEDiscontinued
PREDNISOLONE 5MG · TABLET · ORAL

Approval history

2001-03-16Labeling · Supplement 39AP
1996-10-18Labeling · Supplement 43AP
1991-10-28Labeling · Supplement 42AP
1991-10-28Labeling · Supplement 41AP
1989-12-13Labeling · Supplement 40AP
1973-07-13OriginalAP
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 →