APPLICATION
ANDA080356
TYPE
ANDA
ORIGINAL APPROVAL
1972-01-17
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 116 · standardAP
2024-05-28Labeling · Supplement 110 · standardAP
2001-04-25Manufacturing (CMC) · Supplement 79AP
1998-06-15Manufacturing (CMC) · Supplement 75AP
1998-06-15Manufacturing (CMC) · Supplement 74AP
1997-06-16Manufacturing (CMC) · Supplement 73AP
1995-11-14Labeling · Supplement 72AP
1994-02-08Labeling · Supplement 71AP
1991-01-28Manufacturing (CMC) · Supplement 68AP
1990-06-29Manufacturing (CMC) · Supplement 66AP
1988-02-17Manufacturing (CMC) · Supplement 65AP
1988-02-17Manufacturing (CMC) · Supplement 64AP
1987-11-19Manufacturing (CMC) · Supplement 61AP
1987-11-19Manufacturing (CMC) · Supplement 60AP
1987-10-09Manufacturing (CMC) · Supplement 63AP
1987-09-08Manufacturing (CMC) · Supplement 62AP
1985-06-03Manufacturing (CMC) · Supplement 57AP
1985-06-03Manufacturing (CMC) · Supplement 58AP
1983-12-15Manufacturing (CMC) · Supplement 55AP
1983-12-08Manufacturing (CMC) · Supplement 54AP
1983-08-23Manufacturing (CMC) · Supplement 53AP
1983-07-20Manufacturing (CMC) · Supplement 51AP
1983-07-20Manufacturing (CMC) · Supplement 52AP
1972-03-30Manufacturing (CMC) · Supplement 1AP
1972-01-17OriginalAP
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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