APPLICATION
ANDA076913
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-25
LATEST ACTION
2025-04-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISOLONE SODIUM PHOSPHATEPrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-04-18Manufacturing (CMC) · Supplement 16 · unknownAP
2024-06-05Labeling · Supplement 14 · standardAP
2010-04-16Labeling · Supplement 6AP
2009-06-02Labeling · Supplement 4AP
2007-10-05Manufacturing (CMC) · Supplement 2AP
2005-04-25OriginalAP
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.