Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis. ANDA 85027, held by Padagis US. Hydrocortisone.

As of Nov 14, 2026, ANDA 85027 (Hydrocortisone), held by Padagis US, was first approved by FDA on Nov 30, 1977, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1977
Supplements approved: 9
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 dermatosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 30, 1977	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Jan 3, 2000	Supplement 21Manufacturing	Approved	None posted
Aug 18, 1999	Supplement 20Labeling	Approved	None posted
Aug 18, 1999	Supplement 19Manufacturing	Approved	None posted
Aug 18, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 18, 1996	Supplement 17Labeling	Approved	None posted
Aug 14, 1989	Supplement 16Labeling	Approved	None posted
Jun 11, 1986	Supplement 13Manufacturing	Approved	None posted
Jul 7, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 9Manufacturing	Approved	None posted
Nov 30, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85027
Drugs@FDA: Overview at FDA
Company: Padagis US 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