Hydrocortisone Acetate

ANDA 83128, held by Watson Labs. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 83128 (Hydrocortisone Acetate), held by Watson Labs, was first approved by FDA on Feb 27, 1979, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1979
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Feb 27, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone Acetate25MG/ML · injectable;injection	Hydrocortisone Acetate	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 68Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 67Manufacturing	Approved	None posted
Jun 9, 1998	Supplement 66Manufacturing	Approved	None posted
Jun 16, 1997	Supplement 65Manufacturing	Approved	None posted
Sep 3, 1996	Supplement 64Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 63Labeling	Approved	None posted
Feb 24, 1994	Supplement 62Labeling	Approved	None posted
Jan 26, 1993	Supplement 60Bioequivalence	Approved	None posted
Oct 29, 1992	Supplement 61Manufacturing	Approved	None posted
Jul 30, 1992	Supplement 54Manufacturing	Approved	None posted
May 22, 1992	Supplement 58Labeling	Approved	None posted
Apr 1, 1991	Supplement 59Labeling	Approved	None posted
Feb 11, 1991	Supplement 56Manufacturing	Approved	None posted
Feb 11, 1991	Supplement 55Manufacturing	Approved	None posted
Nov 15, 1989	Supplement 57Labeling	Approved	None posted
Dec 23, 1988	Supplement 53Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 52Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 51Manufacturing	Approved	None posted
Dec 23, 1988	Supplement 50Manufacturing	Approved	None posted
Jun 16, 1986	Supplement 47Manufacturing	Approved	None posted
May 27, 1983	Supplement 43Manufacturing	Approved	None posted
Jun 30, 1982	Supplement 41Manufacturing	Approved	None posted
Feb 27, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 83128
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