APPLICATION
ANDA080354
TYPE
ANDA
ORIGINAL APPROVAL
1972-01-17
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISOLONE · ReferencePrescription
PREDNISOLONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 72 · standardAP
2007-09-16Manufacturing (CMC) · Supplement 54AP
2001-12-04Manufacturing (CMC) · Supplement 48AP
2001-04-25Manufacturing (CMC) · Supplement 46AP
1998-12-30Manufacturing (CMC) · Supplement 44AP
1994-03-30Labeling · Supplement 43AP
1991-03-26Labeling · Supplement 42AP
1991-01-28Manufacturing (CMC) · Supplement 41AP
1985-06-03Manufacturing (CMC) · Supplement 34AP
1985-06-03Manufacturing (CMC) · Supplement 33AP
1983-12-27Manufacturing (CMC) · Supplement 31AP
1983-11-22Manufacturing (CMC) · Supplement 30AP
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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