APPLICATION
ANDA040183
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-22
LATEST ACTION
2025-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 4MG · TABLET · ORAL
Approval history
2025-02-27Labeling · Supplement 24 · standardAP
2019-09-05Labeling · Supplement 18 · standardAP
2004-04-19Labeling · Supplement 4AP
2001-03-16Manufacturing (CMC) · Supplement 2AP
2000-05-31Manufacturing (CMC) · Supplement 1AP
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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