APPLICATION
ANDA080776
TYPE
ANDA
ORIGINAL APPROVAL
1972-06-13
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CORTISONE ACETATEDiscontinued
CORTISONE ACETATE 25MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 53 · standardAP
2024-05-07Labeling · Supplement 44 · standardAP
2002-03-22Manufacturing (CMC) · Supplement 34AP
2000-05-25Manufacturing (CMC) · Supplement 33AP
1998-11-16Manufacturing (CMC) · Supplement 31AP
1998-10-01Manufacturing (CMC) · Supplement 32AP
1996-04-29Labeling · Supplement 30AP
1995-02-15Labeling · Supplement 29AP
1994-05-05Labeling · Supplement 28AP
1993-08-24Manufacturing (CMC) · Supplement 27AP
1991-10-03Manufacturing (CMC) · Supplement 23AP
1988-08-22Labeling · Supplement 22AP
1988-08-22Manufacturing (CMC) · Supplement 20AP
1988-08-22Manufacturing (CMC) · Supplement 19AP
1988-08-22Manufacturing (CMC) · Supplement 21AP
1988-05-27Manufacturing (CMC) · Supplement 18AP
1988-05-27Manufacturing (CMC) · Supplement 16AP
1988-05-27Manufacturing (CMC) · Supplement 14AP
1988-05-27Manufacturing (CMC) · Supplement 17AP
1988-05-27Manufacturing (CMC) · Supplement 15AP
1988-02-19Labeling · Supplement 13AP
1972-06-13OriginalAP
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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