Cortone

NDA 7750, held by Merck. Cortisone Acetate.

As of Nov 13, 2026, NDA 7750 (Cortone), held by Merck, was first approved by FDA on Dec 4, 1950, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1950
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 4, 1950	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cortone25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cortisone Acetate	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Mar 1, 1996	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 18, 1994	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 27, 1993	Supplement 25Labeling · Standard review	Approved	None posted
Nov 30, 1989	Supplement 24Manufacturing · Standard review	Approved	None posted
May 16, 1989	Supplement 18Labeling · Standard review	Approved	None posted
Mar 2, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 1, 1980	Supplement 13Labeling · Standard review	Approved	None posted
Sep 25, 1979	Supplement 12Labeling · Standard review	Approved	None posted
Aug 1, 1979	Supplement 11Labeling · Standard review	Approved	None posted
Dec 4, 1950	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 7750
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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