Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 87795, held by Actavis Mid Atlantic. Hydrocortisone.

As of Nov 14, 2026, ANDA 87795 (Hydrocortisone), held by Actavis Mid Atlantic, was first approved by FDA on May 3, 1983, with 19 approved supplements and 0 published complete response letters.

First approved: May 3, 1983
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (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
May 3, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · cream;topical	Hydrocortisone	Rx

All 20 submissions, including labeling and manufacturing supplements


Apr 26, 2001	Supplement 22Manufacturing	Approved	None posted
Dec 27, 2000	Supplement 21Manufacturing	Approved	None posted
Dec 21, 1998	Supplement 20Manufacturing	Approved	None posted
May 13, 1997	Supplement 19Manufacturing	Approved	None posted
Jun 28, 1996	Supplement 18Manufacturing	Approved	None posted
Feb 7, 1996	Supplement 17Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 16Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 15Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 14Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 13Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 12Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 11Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 10Manufacturing	Approved	None posted
Apr 15, 1991	Supplement 9Labeling	Approved	None posted
Jul 26, 1989	Supplement 8Manufacturing	Approved	None posted
May 13, 1988	Supplement 5Manufacturing	Approved	None posted
May 12, 1988	Supplement 7Manufacturing	Approved	None posted
Jun 12, 1986	Supplement 3Manufacturing	Approved	None posted
Jun 12, 1986	Supplement 2Manufacturing	Approved	None posted
May 3, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87795
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