APPLICATION
ANDA086813
TYPE
ANDA
ORIGINAL APPROVAL
1979-06-01
LATEST ACTION
1998-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREDNISONEDiscontinued
PREDNISONE 20MG · TABLET · ORAL
Approval history
1998-02-20Manufacturing (CMC) · Supplement 27AP
1998-02-20Manufacturing (CMC) · Supplement 25AP
1998-02-20Manufacturing (CMC) · Supplement 26AP
1994-11-02Labeling · Supplement 24AP
1993-12-23Labeling · Supplement 23AP
1991-02-05Labeling · Supplement 22AP
1987-08-19Manufacturing (CMC) · Supplement 21AP
1986-08-01Manufacturing (CMC) · Supplement 19AP
1983-06-10Manufacturing (CMC) · Supplement 11AP
1983-06-10Manufacturing (CMC) · Supplement 10AP
1982-07-21Manufacturing (CMC) · Supplement 8AP
1982-07-21Manufacturing (CMC) · Supplement 2AP
1982-07-21Manufacturing (CMC) · Supplement 7AP
1982-07-21Manufacturing (CMC) · Supplement 3AP
1979-06-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.