← FDA DRUG APPROVALS

FDA NDA · NDA011153

MEDROL

methylprednisolone

Sponsor: PFIZER

APPLICATION
NDA011153
TYPE
NDA
ORIGINAL APPROVAL
1957-10-24
LATEST ACTION
2025-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

MEDROLDiscontinued
METHYLPREDNISOLONE 24MG · TABLET · ORAL
MEDROL · ReferencePrescription
METHYLPREDNISOLONE 16MG · TABLET · ORAL
MEDROL · ReferencePrescription
METHYLPREDNISOLONE 4MG · TABLET · ORAL
MEDROL · ReferencePrescription
METHYLPREDNISOLONE 32MG · TABLET · ORAL
MEDROL · ReferencePrescription
METHYLPREDNISOLONE 8MG · TABLET · ORAL
MEDROL · ReferencePrescription
METHYLPREDNISOLONE 2MG · TABLET · ORAL

Approval history

2025-11-04Labeling · Supplement 82 · standard — Letter ↗AP
2024-06-05Labeling · Supplement 83 · standard — Label ↗AP
2023-12-19Labeling · Supplement 81 · standard — Label ↗AP
2019-08-26Manufacturing (CMC) · Supplement 77 — Letter ↗AP
2018-07-24Labeling · Supplement 75 · standard — Label ↗AP
2013-07-18Manufacturing (CMC) · Supplement 71 · standardAP
2002-10-25Manufacturing (CMC) · Supplement 59 · standardAP
1999-12-01Manufacturing (CMC) · Supplement 58 · standardAP
1993-12-28Labeling · Supplement 51 — Label ↗AP
1993-01-28Manufacturing (CMC) · Supplement 52 · standardAP
1989-01-05Manufacturing (CMC) · Supplement 49 · standardAP
1987-02-24Manufacturing (CMC) · Supplement 47 · standardAP
1983-03-09Labeling · Supplement 46AP
1980-10-08Manufacturing (CMC) · Supplement 44 · standardAP
1980-04-14Labeling · Supplement 43AP
1979-05-30Manufacturing (CMC) · Supplement 40 · standardAP
1979-04-05Manufacturing (CMC) · Supplement 39 · standardAP
1979-04-05Manufacturing (CMC) · Supplement 42 · standardAP
1978-04-11Labeling · Supplement 41AP
1976-09-10Manufacturing (CMC) · Supplement 37 · standardAP
1957-10-24Type 1 - New Molecular Entity · Original · standardAP
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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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