APPLICATION
ANDA080339
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-06
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISOLONEDiscontinued
PREDNISOLONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 50 · standardAP
1994-04-04Labeling · Supplement 49AP
1994-01-24Manufacturing (CMC) · Supplement 48AP
1990-05-10Labeling · Supplement 47AP
1989-11-02Labeling · Supplement 46AP
1989-07-12Labeling · Supplement 45AP
1988-04-07Manufacturing (CMC) · Supplement 43AP
1988-04-07Manufacturing (CMC) · Supplement 44AP
1985-08-09Manufacturing (CMC) · Supplement 41AP
1985-08-09Manufacturing (CMC) · Supplement 42AP
1985-08-09Manufacturing (CMC) · Supplement 40AP
1982-11-05Manufacturing (CMC) · Supplement 35AP
1982-11-05Manufacturing (CMC) · Supplement 36AP
1982-10-13Manufacturing (CMC) · Supplement 34AP
1982-09-07Manufacturing (CMC) · Supplement 33AP
1982-09-07Manufacturing (CMC) · Supplement 32AP
1972-09-06OriginalAP
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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