Cormax

ANDA 74220, held by Hikma. Clobetasol Propionate.

As of Nov 15, 2026, ANDA 74220 (Cormax), held by Hikma, was first approved by FDA on May 16, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: May 16, 1997
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 16, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cormax0.05% · cream;topical	Clobetasol Propionate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 26, 2018	Supplement 10Manufacturing	Approved	None posted
Feb 21, 2001	Supplement 7Manufacturing	Approved	None posted
Oct 23, 2000	Supplement 6Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 4Manufacturing	Approved	None posted
Apr 28, 1998	Supplement 3Labeling	Approved	None posted
Apr 28, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 28, 1998	Supplement 1Manufacturing	Approved	None posted
May 16, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74220
Drugs@FDA: Overview at FDA
Company: Hikma

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