Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 89414, held by Fougera Pharms Inc. Hydrocortisone.

As of Nov 13, 2026, ANDA 89414 (Hydrocortisone), held by Fougera Pharms Inc, was first approved by FDA on Dec 16, 1986, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1986
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Dec 16, 1986	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Apr 1, 1997	Supplement 6Labeling	Approved	None posted
Mar 7, 1996	Supplement 5Manufacturing	Approved	None posted
Nov 8, 1995	Supplement 3Manufacturing	Approved	None posted
Nov 8, 1995	Supplement 4Labeling	Approved	None posted
Dec 16, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89414
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