Medrol

Controls severe or incapacitating allergic conditions. NDA 11153, held by Pfizer. Methylprednisolone.

As of Nov 14, 2026, NDA 11153 (Medrol), held by Pfizer, was first approved by FDA on Oct 24, 1957, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1957
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 24, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

6 strengths and forms


Medrol4MG · tablet;oral	Methylprednisolone	RxReference drug
Medrol2MG · tablet;oral	Methylprednisolone	RxReference drug
Medrol16MG · tablet;oral	Methylprednisolone	RxReference drug
Medrol8MG · tablet;oral	Methylprednisolone	RxReference drug
Medrol24MG · tablet;oral	Methylprednisolone	Discontinued
Medrol32MG · tablet;oral	Methylprednisolone	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Nov 4, 2025	Supplement 82Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 83Labeling · Standard review	Approved	Letter Label
Dec 19, 2023	Supplement 81Labeling · Standard review	Approved	Letter Label
Aug 26, 2019	Supplement 77Manufacturing	Approved	Label Letter
Jul 24, 2018	Supplement 75Labeling · Standard review	Approved	Letter Label
Jul 18, 2013	Supplement 71Manufacturing · Standard review	Approved	None posted
Oct 25, 2002	Supplement 59Manufacturing · Standard review	Approved	None posted
Dec 1, 1999	Supplement 58Manufacturing · Standard review	Approved	None posted
Dec 28, 1993	Supplement 51Labeling	Approved	Label
Jan 28, 1993	Supplement 52Manufacturing · Standard review	Approved	None posted
Jan 5, 1989	Supplement 49Manufacturing · Standard review	Approved	None posted
Feb 24, 1987	Supplement 47Manufacturing · Standard review	Approved	None posted
Mar 9, 1983	Supplement 46Labeling	Approved	None posted
Oct 8, 1980	Supplement 44Manufacturing · Standard review	Approved	None posted
Apr 14, 1980	Supplement 43Labeling	Approved	None posted
May 30, 1979	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 5, 1979	Supplement 42Manufacturing · Standard review	Approved	None posted
Apr 5, 1979	Supplement 39Manufacturing · Standard review	Approved	None posted
Apr 11, 1978	Supplement 41Labeling	Approved	None posted
Sep 10, 1976	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 24, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11153
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