APPLICATION
ANDA083677
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-26
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 20MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 69 · standardAP
2024-05-31Labeling · Supplement 57 · standardAP
2024-05-31Labeling · Supplement 58 · standardAP
2024-05-31Labeling · Supplement 56 · standardAP
2019-02-21Manufacturing (CMC) · Supplement 60AP
2002-04-10Manufacturing (CMC) · Supplement 44AP
2000-11-13Manufacturing (CMC) · Supplement 40AP
2000-03-03Manufacturing (CMC) · Supplement 43AP
1998-10-01Manufacturing (CMC) · Supplement 42AP
1998-06-29Manufacturing (CMC) · Supplement 41AP
1997-11-18Manufacturing (CMC) · Supplement 39AP
1994-11-14Labeling · Supplement 38AP
1994-07-06Labeling · Supplement 33AP
1994-07-06Manufacturing (CMC) · Supplement 34AP
1994-07-06Manufacturing (CMC) · Supplement 32AP
1994-04-14Manufacturing (CMC) · Supplement 36AP
1994-02-09Labeling · Supplement 37AP
1991-04-11Labeling · Supplement 35AP
1991-02-05Manufacturing (CMC) · Supplement 31AP
1990-05-17Labeling · Supplement 23AP
1989-09-25Manufacturing (CMC) · Supplement 29AP
1989-09-25Labeling · Supplement 27AP
1989-09-25Manufacturing (CMC) · Supplement 25AP
1989-09-25Manufacturing (CMC) · Supplement 28AP
1989-09-25Manufacturing (CMC) · Supplement 26AP
1989-09-25Manufacturing (CMC) · Supplement 24AP
1989-09-25Labeling · Supplement 30AP
1987-03-05Manufacturing (CMC) · Supplement 20AP
1987-03-05Manufacturing (CMC) · Supplement 19AP
1987-03-05Manufacturing (CMC) · Supplement 21AP
1987-03-05Manufacturing (CMC) · Supplement 18AP
1987-03-05Manufacturing (CMC) · Supplement 22AP
1983-06-06Manufacturing (CMC) · Supplement 16AP
1982-07-27Manufacturing (CMC) · Supplement 13AP
1982-07-27Manufacturing (CMC) · Supplement 14AP
1974-02-26OriginalAP
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.