Medrol Acetate

NDA 12421, held by Pharmacia And Upjohn. Methylprednisolone Acetate.

As of Nov 14, 2026, NDA 12421 (Medrol Acetate), held by Pharmacia And Upjohn, was first approved by FDA on Jun 21, 1960, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 21, 1960
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 21, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Medrol Acetate0.25% · ointment;topical	Methylprednisolone Acetate	Discontinued
Medrol Acetate1% · ointment;topical	Methylprednisolone Acetate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 2, 1982	Supplement 22Labeling	Approved	None posted
Dec 28, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 29, 1980	Supplement 19Labeling	Approved	None posted
Nov 11, 1977	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 27, 1976	Supplement 17Labeling	Approved	None posted
Jun 21, 1960	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12421
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