APPLICATION
ANDA086596
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-10
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 50MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 24 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 23AP
1995-04-05Labeling · Supplement 20AP
1994-12-23Manufacturing (CMC) · Supplement 22AP
1994-10-11Manufacturing (CMC) · Supplement 21AP
1994-04-04Labeling · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 16AP
1991-03-27Labeling · Supplement 15AP
1987-04-01Manufacturing (CMC) · Supplement 13AP
1986-03-20Manufacturing (CMC) · Supplement 11AP
1979-04-10OriginalAP
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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