APPLICATION
ANDA040256
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-12
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PREDNISONEPrescription
PREDNISONE 10MG · TABLET · ORAL
PREDNISONEPrescription
PREDNISONE 5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 24 · standardAP
2024-05-28Labeling · Supplement 17 · standardAP
2024-05-28Labeling · Supplement 9AP
2008-01-16Labeling · Supplement 4AP
2003-11-20Labeling · Supplement 2AP
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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