APPLICATION
ANDA085161
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-11
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 20MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 97 · standardAP
2024-05-28Labeling · Supplement 91 · standardAP
2001-04-25Manufacturing (CMC) · Supplement 57AP
1998-11-16Manufacturing (CMC) · Supplement 54AP
1997-12-15Manufacturing (CMC) · Supplement 53AP
1995-11-14Labeling · Supplement 52AP
1994-02-08Labeling · Supplement 51AP
1991-08-07Manufacturing (CMC) · Supplement 47AP
1991-01-28Manufacturing (CMC) · Supplement 48AP
1990-06-29Manufacturing (CMC) · Supplement 46AP
1988-08-09Manufacturing (CMC) · Supplement 45AP
1988-08-09Manufacturing (CMC) · Supplement 44AP
1987-11-23Manufacturing (CMC) · Supplement 43AP
1987-11-23Manufacturing (CMC) · Supplement 42AP
1985-06-04Manufacturing (CMC) · Supplement 35AP
1984-01-11Manufacturing (CMC) · Supplement 33AP
1983-11-22Manufacturing (CMC) · Supplement 32AP
1983-09-07Manufacturing (CMC) · Supplement 29AP
1983-09-07Manufacturing (CMC) · Supplement 31AP
1976-11-11OriginalAP
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.
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