Hydrocortisone

ANDA 87796, held by Actavis Mid Atlantic. Hydrocortisone.

As of Nov 14, 2026, ANDA 87796 (Hydrocortisone), held by Actavis Mid Atlantic, was first approved by FDA on Oct 13, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 13, 1982
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 13, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · ointment;topical	Hydrocortisone	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 26, 2001	Supplement 15Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 14Manufacturing	Approved	None posted
Mar 26, 1999	Supplement 13Manufacturing	Approved	None posted
Jun 28, 1996	Supplement 12Manufacturing	Approved	None posted
Feb 7, 1996	Supplement 11Manufacturing	Approved	None posted
Feb 24, 1995	Supplement 10Manufacturing	Approved	None posted
Feb 9, 1994	Supplement 9Labeling	Approved	None posted
May 17, 1993	Supplement 6Labeling	Approved	None posted
Mar 4, 1992	Supplement 8Labeling	Approved	None posted
Jul 26, 1989	Supplement 7Manufacturing	Approved	None posted
Jun 12, 1986	Supplement 5Manufacturing	Approved	None posted
Jun 12, 1986	Supplement 4Manufacturing	Approved	None posted
Aug 11, 1983	Supplement 1Manufacturing	Approved	None posted
Oct 13, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87796
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