APPLICATION
ANDA204072
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-14
LATEST ACTION
2026-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONEPrescription
METHYLPREDNISOLONE 4MG · TABLET · ORAL
Approval history
2026-04-10Labeling · Supplement 13 · standardAP
2024-10-11Labeling · Supplement 11 · standardAP
2024-10-11Labeling · Supplement 10 · standardAP
2018-05-14UNKNOWN · OriginalAP
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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