Embeline

ANDA 74221, held by Hikma. Clobetasol Propionate.

As of Nov 15, 2026, ANDA 74221 (Embeline), held by Hikma, was first approved by FDA on Mar 31, 1995, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1995
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
Mar 31, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Embeline0.05% · ointment;topical	Clobetasol Propionate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 13, 2019	Supplement 8Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 6Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 5Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 1Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 2Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 3Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 4Labeling	Approved	None posted
Mar 31, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74221
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