Anusol Hc

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 88250, held by Salix Pharms. Hydrocortisone.

As of Nov 13, 2026, ANDA 88250 (Anusol Hc), held by Salix Pharms, was first approved by FDA on Jun 6, 1984, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 6, 1984
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Jun 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Anusol Hc2.5% · cream;topical	Hydrocortisone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Aug 11, 2000	Supplement 8Manufacturing	Approved	None posted
Jan 19, 2000	Supplement 7Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 6Manufacturing	Approved	None posted
May 13, 1998	Supplement 4Manufacturing	Approved	None posted
May 13, 1998	Supplement 5Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 3Manufacturing	Approved	None posted
May 19, 1993	Supplement 2Labeling	Approved	None posted
Mar 6, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88250
Drugs@FDA: Overview at FDA
Company: Salix Pharmaceuticals

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