Betoptic S

Treats elevated intraocular pressure (IOP). NDA 19845, held by Novartis. Betaxolol Hydrochloride.

As of Nov 14, 2026, NDA 19845 (Betoptic S), held by Novartis, was first approved by FDA on Dec 29, 1989, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) 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 24 submissions below


Jun 8, 2007	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Medical Review
Dec 29, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Betoptic SEQ 0.25% BASE · suspension/drops;ophthalmic	Betaxolol Hydrochloride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Jun 9, 2021	Supplement 30Labeling · Standard review	Approved	Label Letter
Feb 1, 2017	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 16, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 24, 2016	Supplement 26Manufacturing · Standard review	Approved	Label
May 8, 2008	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 8, 2007	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Medical Review
May 9, 2003	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 4, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 7, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 5, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 23, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 14, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 27, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 22, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 10, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 20, 1990	Supplement 1Labeling	Approved	None posted
Dec 29, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19845
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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