Vanos

NDA 21758, held by Bausch. Fluocinonide.

As of Nov 14, 2026, NDA 21758 (Vanos), held by Bausch, was first approved by FDA on Feb 11, 2005, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 11, 2005
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Mar 2, 2006	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 11, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vanos0.1% · cream;topical	Fluocinonide	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Dec 22, 2016	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 18, 2016	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 16, 2012	Supplement 17Labeling	Approved	Label Letter
Nov 10, 2011	Supplement 16Labeling	Approved	Letter Label
Dec 30, 2010	Supplement 14Labeling	Approved	Letter Label
Mar 8, 2010	Supplement 12Labeling · Standard review	Approved	Letter Label
Dec 13, 2006	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 13, 2006	Supplement 3Manufacturing	Approved	None posted
Mar 2, 2006	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 23, 2005	Supplement 2Manufacturing · Standard review	Approved	Letter
Feb 11, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21758
Drugs@FDA: Overview at FDA
Company: Bausch Health

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