Timoptic In Ocudose

Treats elevated intraocular pressure. NDA 19463, held by Bausch And Lomb Inc. Timolol Maleate.

As of Nov 13, 2026, NDA 19463 (Timoptic In Ocudose), held by Bausch And Lomb Inc, was first approved by FDA on Nov 5, 1986, with 25 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1986
Review: Standard
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

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 5, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Timoptic In OcudoseEQ 0.25% BASE · solution/drops;ophthalmic	Timolol Maleate	RxReference drug
Timoptic In OcudoseEQ 0.5% BASE · solution/drops;ophthalmic	Timolol Maleate	RxReference drug

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 6, 2017	Supplement 31Labeling · Standard review	Approved	Letter Label
Aug 14, 2015	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 30, 2011	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 5, 2006	Supplement 27Labeling · Standard review	Approved	Letter Label
Dec 22, 2003	Supplement 26Labeling · Standard review	Approved	Review Label Letter
Jul 26, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 7, 2001	Supplement 22Labeling · Standard review	Approved	Label
Dec 4, 2001	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 2, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 2, 2000	Supplement 20Labeling · Standard review	Approved	None posted
Aug 14, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 22, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 18, 1998	Supplement 19Labeling · Standard review	Approved	Review
Jun 22, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
May 16, 1997	Supplement 13Labeling · Standard review	Approved	None posted
Dec 2, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 2, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 10, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 18, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Dec 9, 1993	Supplement 9Labeling · Standard review	Approved	None posted
Mar 25, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
May 21, 1992	Supplement 5Labeling	Approved	None posted
May 21, 1992	Supplement 4Labeling	Approved	None posted
Jul 9, 1990	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 9, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 5, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19463
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