APPLICATION
ANDA089247
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-04
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 20MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 39 · standardAP
2002-12-20Manufacturing (CMC) · Supplement 19AP
2002-12-17Manufacturing (CMC) · Supplement 18AP
2002-06-14Manufacturing (CMC) · Supplement 15AP
2002-05-20Labeling · Supplement 16AP
2001-10-24Labeling · Supplement 17AP
2000-08-10Manufacturing (CMC) · Supplement 12AP
2000-05-16Manufacturing (CMC) · Supplement 13AP
2000-05-16Manufacturing (CMC) · Supplement 14AP
1997-12-05Manufacturing (CMC) · Supplement 11AP
1997-02-24Manufacturing (CMC) · Supplement 10AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1995-06-22Manufacturing (CMC) · Supplement 8AP
1994-10-06Labeling · Supplement 7AP
1994-01-12Manufacturing (CMC) · Supplement 5AP
1994-01-06Labeling · Supplement 6AP
1990-02-08Labeling · Supplement 4AP
1990-02-01Manufacturing (CMC) · Supplement 3AP
1988-09-06Manufacturing (CMC) · Supplement 2AP
1988-09-06Labeling · Supplement 1AP
1985-12-04OriginalAP
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.