Hydrocortisone Acetate

ANDA 40259, held by Imperium. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 40259 (Hydrocortisone Acetate), held by Imperium, was first approved by FDA on Jul 29, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1999
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 29, 1999	Original application	Approved	Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone Acetate2.5% · cream;topical	Hydrocortisone Acetate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 24, 2001	Supplement 6Manufacturing	Approved	None posted
Jul 13, 2001	Supplement 2Manufacturing	Approved	None posted
Jul 13, 2001	Supplement 3Manufacturing	Approved	None posted
Jul 13, 2001	Supplement 4Manufacturing	Approved	None posted
Oct 31, 2000	Supplement 1Manufacturing	Approved	None posted
Jul 29, 1999	Original application	Approved	Letter Review

Identifiers

Application: ANDA 40259
Drugs@FDA: Overview at FDA
Company: IMPERIUM

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