APPLICATION
ANDA040194
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-31
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 29 · standardAP
2025-08-01Labeling · Supplement 26 · standardAP
2025-08-01Labeling · Supplement 21 · standardAP
2025-08-01Labeling · Supplement 28 · standardAP
2002-11-20Manufacturing (CMC) · Supplement 6AP
2002-11-20Manufacturing (CMC) · Supplement 7AP
2001-10-12Manufacturing (CMC) · Supplement 4AP
2001-10-12Manufacturing (CMC) · Supplement 5AP
1999-10-29Manufacturing (CMC) · Supplement 3AP
1998-06-23Manufacturing (CMC) · Supplement 2AP
1997-12-05Manufacturing (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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