Clobetasol Propionate

ANDA 74407, held by Fougera Pharms. Clobetasol Propionate.

As of Nov 15, 2026, ANDA 74407 (Clobetasol Propionate), held by Fougera Pharms, was first approved by FDA on Feb 23, 1996, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 23, 1996
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 23, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clobetasol Propionate0.05% · ointment;topical	Clobetasol Propionate	Rx

All 6 submissions, including labeling and manufacturing supplements


Aug 14, 2006	Supplement 7Labeling	Approved	None posted
Mar 5, 2001	Supplement 3Labeling	Approved	None posted
Mar 5, 2001	Supplement 4Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 1Labeling	Approved	None posted
May 8, 1997	Supplement 2Labeling	Approved	None posted
Feb 23, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74407
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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