Levobunolol Hydrochloride

For chronic open-angle glaucoma or ocular hypertension. ANDA 74326, held by Bausch And Lomb Inc. Levobunolol Hydrochloride.

As of Nov 15, 2026, ANDA 74326 (Levobunolol Hydrochloride), held by Bausch And Lomb Inc, was first approved by FDA on Mar 4, 1994, with 20 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1994
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Levobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Mar 4, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levobunolol Hydrochloride0.5% · solution/drops;ophthalmic	Levobunolol Hydrochloride	Rx

All 21 submissions, including labeling and manufacturing supplements


Jun 22, 2023	Supplement 38Labeling · Standard review	Approved	None posted
Jun 22, 2023	Supplement 33Labeling · Standard review	Approved	None posted
Dec 19, 2002	Supplement 19Labeling	Approved	None posted
Nov 27, 2001	Supplement 18Manufacturing	Approved	None posted
Mar 7, 2001	Supplement 17Manufacturing	Approved	None posted
Oct 5, 2000	Supplement 16Manufacturing	Approved	None posted
Jun 27, 2000	Supplement 15Manufacturing	Approved	None posted
May 18, 2000	Supplement 12Manufacturing	Approved	None posted
May 15, 2000	Supplement 14Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 13Manufacturing	Approved	None posted
Jun 7, 1999	Supplement 11Manufacturing	Approved	None posted
Mar 22, 1999	Supplement 10Manufacturing	Approved	None posted
Nov 19, 1998	Supplement 8Manufacturing	Approved	None posted
Oct 8, 1998	Supplement 9Manufacturing	Approved	None posted
Mar 11, 1998	Supplement 6Manufacturing	Approved	None posted
Jan 28, 1998	Supplement 7Manufacturing	Approved	None posted
May 30, 1996	Supplement 5Manufacturing	Approved	None posted
Nov 22, 1995	Supplement 4Manufacturing	Approved	None posted
Nov 22, 1995	Supplement 3Manufacturing	Approved	None posted
May 12, 1994	Supplement 1Manufacturing	Approved	None posted
Mar 4, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74326
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

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