APPLICATION
ANDA080352
TYPE
ANDA
ORIGINAL APPROVAL
1972-04-21
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONE · ReferencePrescription
PREDNISONE 50MG · TABLET · ORAL
PREDNISONE · ReferencePrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONE · ReferencePrescription
PREDNISONE 1MG · TABLET · ORAL
PREDNISONE · ReferencePrescription
PREDNISONE 20MG · TABLET · ORAL
PREDNISONE · ReferencePrescription
PREDNISONE 2.5MG · TABLET · ORAL
PREDNISONE · ReferencePrescription
PREDNISONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 74 · standardAP
2024-05-16Labeling · Supplement 69 · standardAP
2008-11-24Labeling · Supplement 63AP
1997-06-09Manufacturing (CMC) · Supplement 50AP
1997-06-09Manufacturing (CMC) · Supplement 47AP
1997-06-09Manufacturing (CMC) · Supplement 51AP
1997-06-09Manufacturing (CMC) · Supplement 48AP
1997-03-11Manufacturing (CMC) · Supplement 53AP
1996-08-28Manufacturing (CMC) · Supplement 52AP
1995-07-13Labeling · Supplement 49AP
1995-02-22Labeling · Supplement 46AP
1994-10-07Labeling · Supplement 45AP
1994-03-30Labeling · Supplement 43AP
1991-06-07Labeling · Supplement 42AP
1991-05-15Labeling · Supplement 41AP
1989-12-26Labeling · Supplement 39AP
1989-10-13Labeling · Supplement 38AP
1988-09-22Manufacturing (CMC) · Supplement 36AP
1988-09-22Manufacturing (CMC) · Supplement 37AP
1988-09-02Bioequivalence · Supplement 31AP
1984-02-21Manufacturing (CMC) · Supplement 30AP
1982-04-06Manufacturing (CMC) · Supplement 28AP
1972-04-21OriginalAP
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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