Timoptic

Treats elevated intraocular pressure. NDA 18086, held by Bausch And Lomb Inc. Timolol Maleate.

As of Nov 14, 2026, NDA 18086 (Timoptic), held by Bausch And Lomb Inc, was first approved by FDA on Aug 17, 1978, with 56 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1978
Review: Priority
Supplements approved: 56
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE TIMOPTIC Ophthalmic 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 57 submissions below

Date	Submission	Status	Documents
Aug 17, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


TimopticEQ 0.25% BASE · solution/drops;ophthalmic	Timolol Maleate	RxReference drug
TimopticEQ 0.5% BASE · solution/drops;ophthalmic	Timolol Maleate	RxReference drug

All 57 submissions, including labeling and manufacturing supplements


Nov 17, 2021	Supplement 80Labeling · Standard review	Approved	Letter Label
Aug 9, 2016	Supplement 76Labeling · Standard review	Approved	Label Letter
Sep 30, 2011	Supplement 75Labeling · Standard review	Approved	Letter Label
Apr 26, 2006	Supplement 72Labeling · Standard review	Approved	Letter Label
Apr 26, 2006	Supplement 70Labeling · Standard review	Approved	Label Letter
Dec 22, 2003	Supplement 60Manufacturing · Priority review	Approved	Review Label Letter
Dec 6, 2002	Supplement 62Manufacturing · Priority review	Approved	None posted
Apr 29, 2002	Supplement 58Labeling · Standard review	Approved	Letter Label
Apr 17, 2002	Supplement 59Manufacturing · Priority review	Approved	None posted
Dec 5, 2001	Supplement 57Manufacturing · Priority review	Approved	None posted
Nov 30, 2001	Supplement 56Labeling · Standard review	Approved	None posted
Apr 12, 2001	Supplement 54Manufacturing · Priority review	Approved	Letter Label
Sep 18, 2000	Supplement 53Labeling · Standard review	Approved	None posted
Apr 22, 1998	Supplement 49Manufacturing · Priority review	Approved	None posted
Mar 18, 1998	Supplement 52Labeling · Standard review	Approved	Review
Aug 5, 1997	Supplement 51Labeling · Standard review	Approved	None posted
May 16, 1997	Supplement 47Labeling · Standard review	Approved	Review
Dec 2, 1996	Supplement 50Manufacturing · Priority review	Approved	None posted
Jul 18, 1996	Supplement 46Manufacturing · Priority review	Approved	None posted
Apr 16, 1996	Supplement 48Manufacturing · Priority review	Approved	None posted
Apr 25, 1995	Supplement 45Manufacturing · Priority review	Approved	None posted
Feb 24, 1995	Supplement 44Labeling · Standard review	Approved	None posted
Feb 24, 1995	Supplement 43Labeling · Standard review	Approved	None posted
Dec 9, 1993	Supplement 42Labeling · Standard review	Approved	None posted
May 20, 1992	Supplement 35Labeling	Approved	None posted
May 20, 1992	Supplement 37Labeling	Approved	None posted
May 20, 1992	Supplement 38Labeling	Approved	None posted
Mar 19, 1990	Supplement 36Manufacturing · Priority review	Approved	None posted
Jan 15, 1988	Supplement 34Manufacturing · Priority review	Approved	None posted
Aug 4, 1987	Supplement 14Labeling	Approved	None posted
Aug 4, 1987	Supplement 28Labeling	Approved	None posted
Aug 4, 1987	Supplement 32Labeling	Approved	None posted
Aug 4, 1987	Supplement 33Labeling	Approved	None posted
Jun 5, 1987	Supplement 30Manufacturing · Priority review	Approved	None posted
Nov 28, 1986	Supplement 31Manufacturing · Priority review	Approved	None posted
Feb 27, 1986	Supplement 29Labeling	Approved	None posted
Feb 12, 1986	Supplement 26Manufacturing · Priority review	Approved	None posted
Nov 29, 1984	Supplement 27Manufacturing · Priority review	Approved	None posted
Jun 14, 1984	Supplement 24Manufacturing · Priority review	Approved	None posted
Sep 7, 1983	Supplement 22Manufacturing · Priority review	Approved	None posted
Jun 30, 1982	Supplement 19Manufacturing · Priority review	Approved	None posted
Nov 3, 1981	Supplement 18Labeling	Approved	None posted
Oct 27, 1981	Supplement 17Manufacturing · Priority review	Approved	None posted
Oct 9, 1981	Supplement 15Labeling	Approved	None posted
Oct 9, 1981	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 15, 1981	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 31, 1981	Supplement 13Labeling	Approved	None posted
Jun 20, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
May 21, 1980	Supplement 10Labeling	Approved	None posted
May 13, 1980	Supplement 7Labeling	Approved	None posted
Feb 11, 1980	Supplement 9Labeling	Approved	None posted
Jan 8, 1980	Supplement 1Labeling	Approved	None posted
Jan 2, 1980	Supplement 2Labeling	Approved	None posted
Dec 3, 1979	Supplement 5Labeling	Approved	None posted
Jul 20, 1979	Supplement 6Labeling	Approved	None posted
Apr 6, 1979	Supplement 4Labeling	Approved	None posted
Aug 17, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Show all 57

Identifiers

Application: NDA 18086
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