Betagan

NDA 19814, held by Allergan. Levobunolol Hydrochloride.

As of Nov 13, 2026, NDA 19814 (Betagan), held by Allergan, was first approved by FDA on Jun 28, 1989, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1989
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 28, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Betagan0.25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Levobunolol Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Mar 19, 2003	Supplement 17Labeling · Standard review	Approved	None posted
Apr 12, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 4, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 8, 2001	Supplement 12Manufacturing · Standard review	Approved	Label
May 14, 2001	Supplement 11Labeling · Standard review	Approved	Label
Apr 12, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 2, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 21, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
May 1, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 18, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 3, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 14, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 12, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 3, 1992	Supplement 3Labeling	Approved	None posted
Jan 18, 1990	Supplement 2Labeling	Approved	None posted
Jan 4, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 28, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19814
Drugs@FDA: Overview at FDA
Company: Allergan

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