Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 81203, held by Fougera Pharms Inc. Hydrocortisone.

As of Nov 14, 2026, ANDA 81203 (Hydrocortisone), held by Fougera Pharms Inc, was first approved by FDA on May 28, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: May 28, 1993
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
May 28, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone2.5% · ointment;topical	Hydrocortisone	Rx

All 8 submissions, including labeling and manufacturing supplements


Apr 1, 1997	Supplement 7Labeling	Approved	None posted
Mar 7, 1996	Supplement 6Manufacturing	Approved	None posted
Mar 6, 1996	Supplement 1Manufacturing	Approved	None posted
Mar 6, 1996	Supplement 2Labeling	Approved	None posted
Mar 6, 1996	Supplement 4Manufacturing	Approved	None posted
Mar 6, 1996	Supplement 5Labeling	Approved	None posted
Nov 6, 1995	Supplement 3Manufacturing	Approved	None posted
May 28, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 81203
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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