Depo-Medrol

NDA 11757, held by Pfizer. Methylprednisolone Acetate.

As of Nov 14, 2026, NDA 11757 (Depo-Medrol), held by Pfizer, was first approved by FDA on May 27, 1959, with 30 approved supplements and 0 published complete response letters.

First approved: May 27, 1959
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE A. FOR INTRAMUSCULAR ADMINISTRATION 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 intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension 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 31 submissions below

Date	Submission	Status	Documents
May 27, 1959	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

3 strengths and forms


Depo-Medrol40MG/ML · injectable;injection	Methylprednisolone Acetate	RxReference drug
Depo-Medrol20MG/ML · injectable;injection	Methylprednisolone Acetate	RxReference drug
Depo-Medrol80MG/ML · injectable;injection	Methylprednisolone Acetate	RxReference drug

All 31 submissions, including labeling and manufacturing supplements


Nov 4, 2025	Supplement 124Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 125Labeling · Standard review	Approved	Letter Label
Dec 20, 2023	Supplement 123Labeling · Standard review	Approved	Letter Label
May 27, 2021	Supplement 120Labeling · Standard review	Approved	Label Letter
Feb 11, 2021	Supplement 119Labeling · Standard review	Approved	Letter Label
Jul 24, 2018	Supplement 114Labeling · Standard review	Approved	Letter Label
Mar 15, 2017	Supplement 111Labeling · Standard review	Approved	Label Letter
Sep 8, 2016	Supplement 104Labeling · Standard review	Approved	Letter Label
Jul 3, 2014	Supplement 103Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 102Manufacturing · Standard review	Approved	None posted
Oct 11, 2013	Supplement 98Manufacturing · Standard review	Approved	None posted
Oct 7, 2013	Supplement 97Manufacturing · Standard review	Approved	None posted
Apr 7, 2009	Supplement 86Labeling · Standard review	Approved	Letter Label
Apr 7, 2009	Supplement 85Labeling · Standard review	Approved	Label Letter
May 22, 2002	Supplement 79Manufacturing · Standard review	Approved	None posted
Apr 4, 2000	Supplement 78Manufacturing · Standard review	Approved	None posted
Jan 24, 1995	Supplement 75Manufacturing · Standard review	Approved	None posted
Jan 7, 1994	Supplement 72Manufacturing · Standard review	Approved	None posted
Dec 28, 1993	Supplement 70Manufacturing · Standard review	Approved	None posted
Nov 15, 1990	Supplement 64Manufacturing · Standard review	Approved	None posted
Dec 14, 1989	Supplement 63Labeling	Approved	None posted
Jan 5, 1989	Supplement 59Manufacturing · Standard review	Approved	None posted
May 12, 1986	Supplement 60Labeling	Approved	None posted
May 12, 1986	Supplement 55Labeling	Approved	None posted
May 12, 1986	Supplement 53Labeling	Approved	None posted
Mar 9, 1983	Supplement 58Labeling	Approved	None posted
Mar 9, 1983	Supplement 57Labeling	Approved	None posted
Feb 17, 1981	Supplement 50Manufacturing · Standard review	Approved	None posted
Jul 29, 1980	Supplement 54Manufacturing · Standard review	Approved	None posted
Jul 12, 1978	Supplement 52Labeling	Approved	None posted
May 27, 1959	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 11757
Drugs@FDA: Overview at FDA
Company: Pfizer

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