Hydrocortisone

ANDA 86257, held by Sun Pharma Canada. Hydrocortisone.

As of Nov 14, 2026, ANDA 86257 (Hydrocortisone), held by Sun Pharma Canada, was first approved by FDA on Jul 24, 1978, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1978
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jul 24, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · ointment;topical	Hydrocortisone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Apr 29, 1993	Supplement 25Labeling	Approved	None posted
Oct 19, 1992	Supplement 24Labeling	Approved	None posted
Apr 16, 1991	Supplement 23Labeling	Approved	None posted
Nov 21, 1990	Supplement 22Manufacturing	Approved	None posted
Jul 21, 1989	Supplement 21Manufacturing	Approved	None posted
Feb 7, 1989	Supplement 20Labeling	Approved	None posted
Apr 11, 1988	Supplement 18Labeling	Approved	None posted
Jul 24, 1986	Supplement 15Manufacturing	Approved	None posted
Apr 8, 1985	Supplement 12Manufacturing	Approved	None posted
Jul 3, 1984	Supplement 7Manufacturing	Approved	None posted
Aug 26, 1983	Supplement 8Manufacturing	Approved	None posted
May 24, 1982	Supplement 6Manufacturing	Approved	None posted
Jul 24, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86257
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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