Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 89682, held by Actavis Mid Atlantic. Hydrocortisone.

As of Nov 13, 2026, ANDA 89682 (Hydrocortisone), held by Actavis Mid Atlantic, was first approved by FDA on Mar 10, 1988, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 10, 1988
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 10, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone2.5% · cream;topical	Hydrocortisone	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Dec 13, 2001	Supplement 20Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 15Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 16Manufacturing	Approved	None posted
Jul 11, 2001	Supplement 17Labeling	Approved	None posted
Jul 11, 2001	Supplement 18Manufacturing	Approved	None posted
Apr 26, 2001	Supplement 14Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 13Manufacturing	Approved	None posted
Dec 30, 1999	Supplement 12Manufacturing	Approved	None posted
Dec 21, 1998	Supplement 8Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 9Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 10Manufacturing	Approved	None posted
Nov 20, 1998	Supplement 11Labeling	Approved	None posted
Sep 13, 1996	Supplement 4Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 5Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 6Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 7Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 1Labeling	Approved	None posted
Nov 10, 1994	Supplement 2Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 3Manufacturing	Approved	None posted
Mar 10, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89682
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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