Cortisone Acetate

ANDA 85884, held by Watson Labs. Cortisone Acetate.

As of Nov 15, 2026, ANDA 85884 (Cortisone Acetate), held by Watson Labs, was first approved by FDA on May 15, 1978, with 18 approved supplements and 0 published complete response letters.

First approved: May 15, 1978
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
May 15, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Mar 18, 1999	Supplement 30Manufacturing	Approved	None posted
Mar 18, 1999	Supplement 29Manufacturing	Approved	None posted
Mar 18, 1999	Supplement 28Manufacturing	Approved	None posted
Mar 18, 1999	Supplement 27Manufacturing	Approved	None posted
Apr 24, 1997	Supplement 26Manufacturing	Approved	None posted
Jul 13, 1994	Supplement 25Labeling	Approved	None posted
Apr 11, 1994	Supplement 20Manufacturing	Approved	None posted
Apr 11, 1994	Supplement 19Manufacturing	Approved	None posted
Apr 11, 1994	Supplement 18Manufacturing	Approved	None posted
Mar 10, 1994	Supplement 24Labeling	Approved	None posted
Dec 4, 1990	Supplement 23Labeling	Approved	None posted
Dec 5, 1989	Supplement 22Labeling	Approved	None posted
Aug 31, 1989	Supplement 21Labeling	Approved	None posted
Sep 4, 1986	Supplement 16Manufacturing	Approved	None posted
Mar 11, 1986	Supplement 15Manufacturing	Approved	None posted
Sep 26, 1983	Supplement 11Manufacturing	Approved	None posted
Sep 26, 1983	Supplement 10Manufacturing	Approved	None posted
Jan 18, 1983	Supplement 7Manufacturing	Approved	None posted
May 15, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85884
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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