APPLICATION
ANDA088465
TYPE
ANDA
ORIGINAL APPROVAL
1984-06-01
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 9 · standardAP
2024-05-29Labeling · Supplement 8 · standardAP
1994-11-14Labeling · Supplement 5AP
1994-02-09Labeling · Supplement 4AP
1991-12-16Manufacturing (CMC) · Supplement 3AP
1984-06-01OriginalAP
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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