Vosol

Treats superficial infections of the external auditory canal caused by organisms…. NDA 12179, held by Hikma. Acetic Acid, Glacial.

As of Nov 13, 2026, NDA 12179 (Vosol), held by Hikma, was first approved by FDA on May 17, 1960, with 11 approved supplements and 0 published complete response letters.

First approved: May 17, 1960
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 17, 1960	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vosol2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;otic	Acetic Acid, Glacial	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


Oct 16, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Supplement 18Labeling · Standard review	Approved	None posted
Dec 21, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 29, 1988	Supplement 15Labeling	Approved	None posted
Aug 3, 1987	Supplement 12Labeling	Approved	None posted
Aug 26, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 24, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 6, 1984	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 6, 1984	Supplement 8Labeling	Approved	None posted
Jun 2, 1975	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 16, 1974	Supplement 5	Approved	None posted
May 17, 1960	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12179
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