Solu-Medrol

NDA 11856, held by Pharmacia And Upjohn. Methylprednisolone Sodium Succinate.

As of Nov 14, 2026, NDA 11856 (Solu-Medrol), held by Pharmacia And Upjohn, was first approved by FDA on May 18, 1959, with 47 approved supplements and 0 published complete response letters.

First approved: May 18, 1959
Review: Standard
Supplements approved: 47
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 48 submissions below

Date	Submission	Status	Documents
May 18, 1959	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

5 strengths and forms


Solu-MedrolEQ 40MG BASE/VIAL · injectable;injection	Methylprednisolone Sodium Succinate	RxReference drug
Solu-MedrolEQ 125MG BASE/VIAL · injectable;injection	Methylprednisolone Sodium Succinate	RxReference drug
Solu-MedrolEQ 500MG BASE/VIAL · injectable;injection	Methylprednisolone Sodium Succinate	RxReference drug
Solu-MedrolEQ 1GM BASE/VIAL · injectable;injection	Methylprednisolone Sodium Succinate	RxReference drug
Solu-MedrolEQ 2GM BASE/VIAL · injectable;injection	Methylprednisolone Sodium Succinate	RxReference drug

All 48 submissions, including labeling and manufacturing supplements


Nov 4, 2025	Supplement 143Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 144Labeling · Standard review	Approved	Letter Label
Dec 20, 2023	Supplement 141Labeling · Standard review	Approved	Letter Label
Oct 27, 2021	Supplement 139Manufacturing	Approved	Label
May 27, 2021	Supplement 136Labeling · Standard review	Approved	Label Letter
Jul 24, 2018	Supplement 133Labeling · Standard review	Approved	Letter Label
Mar 28, 2018	Supplement 131Labeling · Standard review	Approved	Label Letter
Sep 8, 2016	Supplement 124Labeling · Standard review	Approved	Letter Label
Sep 8, 2016	Supplement 126Labeling · Standard review	Approved	Letter Label
Aug 6, 2015	Supplement 127Manufacturing · Standard review	Approved	None posted
Jul 22, 2014	Supplement 121Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 123Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 122Manufacturing · Standard review	Approved	None posted
Apr 4, 2014	Supplement 116Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 119Manufacturing · Standard review	Approved	None posted
Oct 20, 2011	Supplement 104Labeling	Approved	Label Letter
Oct 20, 2011	Supplement 103Manufacturing · Standard review	Approved	Letter Label
Jun 24, 2010	Supplement 107Labeling	Approved	Label Letter
Oct 21, 2002	Supplement 94Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 93Manufacturing · Standard review	Approved	None posted
Mar 16, 1999	Supplement 92Manufacturing · Standard review	Approved	None posted
Feb 26, 1998	Supplement 91Manufacturing · Standard review	Approved	None posted
Sep 15, 1994	Supplement 87Manufacturing · Standard review	Approved	None posted
Apr 22, 1994	Supplement 72Manufacturing · Standard review	Approved	None posted
Apr 6, 1994	Supplement 84Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 81Manufacturing · Standard review	Approved	None posted
Nov 5, 1993	Supplement 78Manufacturing · Standard review	Approved	None posted
Sep 4, 1991	Supplement 77Labeling	Approved	None posted
Dec 7, 1990	Supplement 73Manufacturing · Standard review	Approved	None posted
Apr 24, 1990	Supplement 69Manufacturing · Standard review	Approved	None posted
Oct 2, 1989	Supplement 67Manufacturing · Standard review	Approved	None posted
Jul 11, 1989	Supplement 68Manufacturing · Standard review	Approved	None posted
Mar 22, 1989	Supplement 55Labeling	Approved	None posted
Dec 8, 1986	Supplement 58Manufacturing · Standard review	Approved	None posted
Dec 8, 1986	Supplement 62Manufacturing · Standard review	Approved	None posted
Feb 14, 1986	Supplement 59Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 60Manufacturing · Standard review	Approved	None posted
Jan 23, 1986	Supplement 61Manufacturing · Standard review	Approved	None posted
Mar 28, 1985	Supplement 57Manufacturing · Standard review	Approved	None posted
Feb 27, 1985	Supplement 53Manufacturing · Standard review	Approved	None posted
May 3, 1983	Supplement 54Labeling	Approved	None posted
Oct 16, 1981	Supplement 49Manufacturing · Standard review	Approved	None posted
Aug 11, 1981	Supplement 44Manufacturing · Standard review	Approved	None posted
Feb 20, 1981	Supplement 50Labeling	Approved	None posted
Sep 30, 1980	Supplement 47Manufacturing · Standard review	Approved	None posted
Apr 28, 1980	Supplement 46Manufacturing · Standard review	Approved	None posted
Nov 13, 1979	Supplement 43Labeling	Approved	None posted
May 18, 1959	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 11856
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters