APPLICATION
ANDA088703
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-08
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISONE · ReferencePrescription
PREDNISONE 5MG/5ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 32 · standardAP
2024-05-16Labeling · Supplement 31 · standardAP
2002-11-27Manufacturing (CMC) · Supplement 25AP
2002-11-27Labeling · Supplement 24AP
1999-11-19Manufacturing (CMC) · Supplement 22AP
1998-12-01Manufacturing (CMC) · Supplement 23AP
1998-01-15Manufacturing (CMC) · Supplement 20AP
1998-01-15Manufacturing (CMC) · Supplement 19AP
1996-12-13Labeling · Supplement 16AP
1996-12-13Manufacturing (CMC) · Supplement 15AP
1996-08-28Manufacturing (CMC) · Supplement 18AP
1995-07-13Labeling · Supplement 17AP
1995-02-22Labeling · Supplement 14AP
1994-10-07Labeling · Supplement 13AP
1994-03-30Labeling · Supplement 12AP
1992-06-15Manufacturing (CMC) · Supplement 10AP
1991-06-05Labeling · Supplement 11AP
1990-02-21Labeling · Supplement 9AP
1989-10-13Labeling · Supplement 8AP
1988-05-11Manufacturing (CMC) · Supplement 5AP
1988-05-11Manufacturing (CMC) · Supplement 6AP
1988-02-23Labeling · Supplement 4AP
1984-11-08OriginalAP
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.