Levobunolol Hydrochloride

ANDA 74307, held by Bausch And Lomb. Levobunolol Hydrochloride.

As of Nov 15, 2026, ANDA 74307 (Levobunolol Hydrochloride), held by Bausch And Lomb, was first approved by FDA on Mar 4, 1994, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 4, 1994
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levobunolol Hydrochloride0.25% · solution/drops;ophthalmic	Levobunolol Hydrochloride	Discontinued

All 19 submissions, including labeling and manufacturing supplements


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
Nov 19, 1998	Supplement 9Manufacturing	Approved	None posted
Sep 8, 1998	Supplement 10Manufacturing	Approved	None posted
Mar 11, 1998	Supplement 7Manufacturing	Approved	None posted
Jan 28, 1998	Supplement 8Manufacturing	Approved	None posted
May 30, 1996	Supplement 5Manufacturing	Approved	None posted
May 28, 1996	Supplement 6Manufacturing	Approved	None posted
Nov 20, 1995	Supplement 4Manufacturing	Approved	None posted
Nov 20, 1995	Supplement 2Manufacturing	Approved	None posted
May 23, 1994	Supplement 1Manufacturing	Approved	None posted
Mar 4, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74307
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