Hydrocortisone Acetate

ANDA 85981, held by X Gen Pharms. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 85981 (Hydrocortisone Acetate), held by X Gen Pharms, was first approved by FDA on May 9, 1978, with 2 approved supplements and 0 published complete response letters.

First approved: May 9, 1978
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 9, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone Acetate100% · powder;for rx compounding	Hydrocortisone Acetate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 21, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 1Manufacturing	Approved	None posted
May 9, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85981
Drugs@FDA: Overview at FDA
Company: X-Gen 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