Cortisone Acetate

ANDA 80776, held by Hikma. Cortisone Acetate.

As of Nov 15, 2026, ANDA 80776 (Cortisone Acetate), held by Hikma, was first approved by FDA on Jun 13, 1972, with 21 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1972
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jun 13, 1972	Original application	Approved	None posted

Products

1 strengths and forms

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

All 22 submissions, including labeling and manufacturing supplements


Jun 5, 2024	Supplement 53Labeling · Standard review	Approved	None posted
May 7, 2024	Supplement 44Labeling · Standard review	Approved	None posted
Mar 22, 2002	Supplement 34Manufacturing	Approved	None posted
May 25, 2000	Supplement 33Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 31Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 32Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 30Labeling	Approved	None posted
Feb 15, 1995	Supplement 29Labeling	Approved	None posted
May 5, 1994	Supplement 28Labeling	Approved	None posted
Aug 24, 1993	Supplement 27Manufacturing	Approved	None posted
Oct 3, 1991	Supplement 23Manufacturing	Approved	None posted
Aug 22, 1988	Supplement 22Labeling	Approved	None posted
Aug 22, 1988	Supplement 21Manufacturing	Approved	None posted
Aug 22, 1988	Supplement 20Manufacturing	Approved	None posted
Aug 22, 1988	Supplement 19Manufacturing	Approved	None posted
May 27, 1988	Supplement 18Manufacturing	Approved	None posted
May 27, 1988	Supplement 17Manufacturing	Approved	None posted
May 27, 1988	Supplement 16Manufacturing	Approved	None posted
May 27, 1988	Supplement 15Manufacturing	Approved	None posted
May 27, 1988	Supplement 14Manufacturing	Approved	None posted
Feb 19, 1988	Supplement 13Labeling	Approved	None posted
Jun 13, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80776
Drugs@FDA: Overview at FDA
Company: Hikma

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