Clobetasol Propionate

ANDA 78854, held by Actavis Mid Atlantic. Clobetasol Propionate.

As of Nov 15, 2026, ANDA 78854 (Clobetasol Propionate), held by Actavis Mid Atlantic, was first approved by FDA on Jun 7, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 7, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 7, 2011	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clobetasol Propionate0.05% · shampoo;topical	Clobetasol Propionate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 13, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jun 7, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 78854
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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