← FDA DRUG APPROVALS

FDA NDA · NDA011856

SOLU-MEDROL

methylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN

APPLICATION

NDA011856

TYPE

NDA

ORIGINAL APPROVAL

1959-05-18

LATEST ACTION

2025-11-04

ROUTE

INTRAMUSCULAR, INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

SOLU-MEDROL · ReferencePrescription

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

SOLU-MEDROL · ReferencePrescription

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION

SOLU-MEDROL · ReferencePrescription

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

SOLU-MEDROL · ReferencePrescription

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

SOLU-MEDROL · ReferencePrescription

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-11-04Labeling · Supplement 143 · standard — Letter ↗AP

2024-06-05Labeling · Supplement 144 · standard — Label ↗AP

2023-12-20Labeling · Supplement 141 · standard — Label ↗AP

2021-10-27Manufacturing (CMC) · Supplement 139 — Label ↗AP

2021-05-27Labeling · Supplement 136 · standard — Letter ↗AP

2018-07-24Labeling · Supplement 133 · standard — Label ↗AP

2018-03-28Labeling · Supplement 131 · standard — Label ↗AP

2016-09-08Labeling · Supplement 126 · standard — Letter ↗AP

2016-09-08Labeling · Supplement 124 · standard — Letter ↗AP

2015-08-06Manufacturing (CMC) · Supplement 127 · standardAP

2014-07-22Manufacturing (CMC) · Supplement 121 · standardAP

2014-07-03Labeling · Supplement 123 · standard — Letter ↗AP

2014-06-09Manufacturing (CMC) · Supplement 122 · standardAP

2014-04-04Manufacturing (CMC) · Supplement 116 · standardAP

2014-03-28Manufacturing (CMC) · Supplement 119 · standardAP

2011-10-20Labeling · Supplement 104 · unknown — Label ↗AP

2011-10-20Manufacturing (CMC) · Supplement 103 · standard — Letter ↗AP

2010-06-24Labeling · Supplement 107 · unknown — Letter ↗AP

2002-10-21Manufacturing (CMC) · Supplement 94 · standardAP

2000-04-03Manufacturing (CMC) · Supplement 93 · standardAP

1999-03-16Manufacturing (CMC) · Supplement 92 · standardAP

1998-02-26Manufacturing (CMC) · Supplement 91 · standardAP

1994-09-15Manufacturing (CMC) · Supplement 87 · standardAP

1994-04-22Manufacturing (CMC) · Supplement 72 · standardAP

1994-04-06Manufacturing (CMC) · Supplement 84 · standardAP

1994-03-25Manufacturing (CMC) · Supplement 81 · standardAP

1993-11-05Manufacturing (CMC) · Supplement 78 · standardAP

1991-09-04Labeling · Supplement 77AP

1990-12-07Manufacturing (CMC) · Supplement 73 · standardAP

1990-04-24Manufacturing (CMC) · Supplement 69 · standardAP

1989-10-02Manufacturing (CMC) · Supplement 67 · standardAP

1989-07-11Manufacturing (CMC) · Supplement 68 · standardAP

1989-03-22Labeling · Supplement 55AP

1986-12-08Manufacturing (CMC) · Supplement 58 · standardAP

1986-12-08Manufacturing (CMC) · Supplement 62 · standardAP

1986-02-14Manufacturing (CMC) · Supplement 59 · standardAP

1986-01-31Manufacturing (CMC) · Supplement 60 · standardAP

1986-01-23Manufacturing (CMC) · Supplement 61 · standardAP

1985-03-28Manufacturing (CMC) · Supplement 57 · standardAP

1985-02-27Manufacturing (CMC) · Supplement 53 · standardAP

VIEW ON DRUGS@FDA ↗

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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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