Cortisone Acetate

NDA 8126, held by Pharmacia And Upjohn. Cortisone Acetate.

As of Nov 13, 2026, NDA 8126 (Cortisone Acetate), held by Pharmacia And Upjohn, was first approved by FDA on Nov 2, 1951, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 2, 1951
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
Nov 2, 1951	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Cortisone Acetate25MG · tablet;oral	Cortisone Acetate	Discontinued
Cortisone Acetate25MG/ML · injectable;injection	Cortisone Acetate	Discontinued
Cortisone Acetate5MG · tablet;oral	Cortisone Acetate	Discontinued
Cortisone Acetate10MG · tablet;oral	Cortisone Acetate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 21, 1994	Supplement 38Manufacturing · Standard review	Approved	None posted
Dec 28, 1993	Supplement 35Labeling	Approved	None posted
Dec 24, 1991	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 8, 1978	Supplement 27Labeling	Approved	None posted
May 16, 1977	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 2, 1951	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8126
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