U-Cort

ANDA 89472, held by Sun Pharma Canada. Hydrocortisone Acetate.

As of Nov 15, 2026, ANDA 89472 (U-Cort), held by Sun Pharma Canada, was first approved by FDA on Jun 13, 1988, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1988
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 13, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
U-Cort1% · cream;topical	Hydrocortisone Acetate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jun 17, 2013	Supplement 23Labeling	Approved	None posted
Oct 4, 2006	Supplement 19Labeling	Approved	None posted
Jun 7, 2006	Supplement 22Labeling	Approved	None posted
Apr 24, 1997	Supplement 7Manufacturing	Approved	None posted
Apr 24, 1997	Supplement 8Labeling	Approved	None posted
Sep 11, 1992	Supplement 6Labeling	Approved	None posted
Apr 5, 1990	Supplement 2Manufacturing	Approved	None posted
Oct 10, 1989	Supplement 4Manufacturing	Approved	None posted
Jan 23, 1989	Supplement 1Labeling	Approved	None posted
Jun 13, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89472
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