Cortisone Acetate

NDA 8284, held by Panray. Cortisone Acetate.

As of Nov 13, 2026, NDA 8284 (Cortisone Acetate), held by Panray, was first approved by FDA on Jan 14, 1952, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 14, 1952
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 14, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Cortisone Acetate25MG · tablet;oral	Cortisone Acetate	Discontinued
Cortisone Acetate5MG · tablet;oral	Cortisone Acetate	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 9, 1980	Supplement 7Labeling	Approved	None posted
Jan 14, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8284
Drugs@FDA: Overview at FDA
Company: Panray

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