APPLICATION
ANDA088810
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-20
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
PREDNISONE INTENSOL · ReferencePrescription
PREDNISONE 5MG/ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 30 · standardAP
2020-12-02Manufacturing (CMC) · Supplement 29 · standardAP
2001-05-04Manufacturing (CMC) · Supplement 18AP
2001-01-11Manufacturing (CMC) · Supplement 17AP
1996-08-28Manufacturing (CMC) · Supplement 16AP
1995-07-13Labeling · Supplement 15AP
1995-02-22Labeling · Supplement 14AP
1994-10-07Labeling · Supplement 13AP
1994-03-30Labeling · Supplement 12AP
1993-10-29Manufacturing (CMC) · Supplement 11AP
1991-07-10Labeling · Supplement 10AP
1991-07-10Labeling · Supplement 9AP
1990-09-11Manufacturing (CMC) · Supplement 6AP
1990-02-05Labeling · Supplement 8AP
1989-10-13Labeling · Supplement 7AP
1989-01-24Manufacturing (CMC) · Supplement 5AP
1989-01-24Manufacturing (CMC) · Supplement 4AP
1988-11-29Bioequivalence · Supplement 1AP
1985-02-20OriginalAP
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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