Istalol

Treats elevated intraocular pressure. NDA 21516, held by Bausch And Lomb. Timolol Maleate.

As of Nov 15, 2026, NDA 21516 (Istalol), held by Bausch And Lomb, was first approved by FDA on Jun 4, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 4, 2004
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ISTALOL is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ISTALOL is a beta adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 4, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
IstalolEQ 0.5% BASE · solution/drops;ophthalmic	Timolol Maleate	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Jul 25, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Jun 17, 2013	Supplement 5Labeling	Approved	Letter Label
Nov 15, 2012	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 4, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21516
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