Levobunolol Hydrochloride

ANDA 74850, held by Chartwell Rx. Levobunolol Hydrochloride.

As of Nov 15, 2026, ANDA 74850 (Levobunolol Hydrochloride), held by Chartwell Rx, was first approved by FDA on Oct 28, 1996, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1996
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 28, 1996	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Apr 8, 2005	Supplement 13Labeling	Approved	None posted
Dec 23, 2002	Supplement 12Manufacturing	Approved	None posted
Oct 29, 2002	Supplement 10Labeling	Approved	None posted
Oct 1, 2002	Supplement 11Manufacturing	Approved	None posted
Aug 2, 2002	Supplement 8Manufacturing	Approved	None posted
Mar 27, 2002	Supplement 9Manufacturing	Approved	None posted
Apr 28, 2000	Supplement 6Manufacturing	Approved	None posted
Apr 7, 2000	Supplement 7Manufacturing	Approved	None posted
May 7, 1999	Supplement 3Manufacturing	Approved	None posted
Mar 23, 1999	Supplement 5Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 2Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 4Manufacturing	Approved	None posted
Jun 4, 1998	Supplement 1Manufacturing	Approved	None posted
Oct 28, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74850
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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