APPLICATION
ANDA085162
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-12
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 85 · standardAP
2024-05-28Labeling · Supplement 79 · standardAP
2001-04-25Manufacturing (CMC) · Supplement 48AP
1998-11-20Manufacturing (CMC) · Supplement 44AP
1998-06-12Manufacturing (CMC) · Supplement 43AP
1997-06-16Manufacturing (CMC) · Supplement 42AP
1995-11-14Labeling · Supplement 41AP
1994-02-08Labeling · Supplement 40AP
1991-08-07Manufacturing (CMC) · Supplement 36AP
1991-01-28Manufacturing (CMC) · Supplement 37AP
1990-06-29Manufacturing (CMC) · Supplement 35AP
1988-09-09Manufacturing (CMC) · Supplement 34AP
1988-09-09Manufacturing (CMC) · Supplement 33AP
1987-11-23Manufacturing (CMC) · Supplement 32AP
1987-11-23Manufacturing (CMC) · Supplement 31AP
1984-03-29Manufacturing (CMC) · Supplement 27AP
1984-01-16Manufacturing (CMC) · Supplement 26AP
1983-11-22Manufacturing (CMC) · Supplement 25AP
1983-09-07Manufacturing (CMC) · Supplement 24AP
1983-09-07Manufacturing (CMC) · Supplement 22AP
1976-11-12OriginalAP
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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