APPLICATION
ANDA040571
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-25
LATEST ACTION
2025-02-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISOLONEPrescription
PREDNISOLONE 15MG/5ML · SOLUTION · ORAL
Approval history
2025-02-13Manufacturing (CMC) · Supplement 5 · unknownAP
2024-06-05Labeling · Supplement 4 · standardAP
2005-08-25OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.