Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis. ANDA 85025, held by Padagis US. Hydrocortisone.

As of Nov 14, 2026, ANDA 85025 (Hydrocortisone), held by Padagis US, was first approved by FDA on Apr 21, 1983, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 21, 1983
Supplements approved: 6
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 7 submissions below

Date	Submission	Status	Documents
Apr 21, 1983	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Dec 27, 1999	Supplement 18Manufacturing	Approved	None posted
May 8, 1996	Supplement 16Manufacturing	Approved	None posted
May 8, 1996	Supplement 17Labeling	Approved	None posted
Jun 11, 1986	Supplement 13Manufacturing	Approved	None posted
Apr 21, 1983	Original application	Approved	None posted
Jun 30, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 9Manufacturing	Approved	None posted

Identifiers

Application: ANDA 85025
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