Timoptic-Xe

Treats elevated intraocular pressure. NDA 20330, held by Bausch And Lomb Inc. Timolol Maleate.

As of Nov 14, 2026, NDA 20330 (Timoptic-Xe), held by Bausch And Lomb Inc, was first approved by FDA on Nov 4, 1993, with 25 approved supplements and 0 published complete response letters.

First approved: Nov 4, 1993
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in 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 26 submissions below

Date	Submission	Status	Documents
Nov 4, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Timoptic-XeEQ 0.25% BASE · solution, gel forming/drops;ophthalmic	Timolol Maleate	RxReference drug
Timoptic-XeEQ 0.5% BASE · solution, gel forming/drops;ophthalmic	Timolol Maleate	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Jul 16, 2018	Supplement 32Labeling · Standard review	Approved	Letter Label
Oct 20, 2015	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 8, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Sep 30, 2011	Supplement 27Labeling	Approved	Letter Label
Apr 26, 2006	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 26, 2006	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 11, 2004	Supplement 19Labeling · Standard review	Approved	Letter Label
Aug 11, 2004	Supplement 18Manufacturing · Standard review	Approved	Letter Label
Dec 22, 2003	Supplement 17Labeling · Standard review	Approved	Review Label Letter
Dec 4, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 3, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Sep 18, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Jun 7, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 2, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 22, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 18, 1998	Supplement 11Labeling · Standard review	Approved	Review
Dec 2, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 18, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 11, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 14, 1996	Supplement 5Labeling · Standard review	Approved	None posted
May 18, 1995	Supplement 3Labeling · Standard review	Approved	None posted
Apr 25, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 21, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Jun 22, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 4, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20330
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