Levobunolol Hydrochloride

Sold as Betagan. Every FDA application for this active ingredient: 2 branded and 8 generic.

As of Nov 15, 2026, FDA lists 10 applications for Levobunolol Hydrochloride (sold as Betagan), first approved Dec 19, 1985, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 19, 1985
Applications: 10
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Levobunolol HCl	Part D	$1.4M	-5%	12,489

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LEVOBUNOLOL 0.5% EYE DROPS: $2.80 per MLGeneric · +23% in a year

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 19, 1985	BetaganNDA 19219 · New molecular entity	Allergan	22	Marketed
Jun 28, 1989	BetaganNDA 19814 · New dosage form	Allergan	16	Discontinued
Mar 4, 1994	Levobunolol HydrochlorideANDA 74307	Bausch And Lomb	18	Discontinued
Mar 4, 1994	Levobunolol HydrochlorideANDA 74326	Bausch And Lomb Inc	20	Marketed
Oct 28, 1996	Levobunolol HydrochlorideANDA 74850	Chartwell Rx	13	Discontinued
Oct 28, 1996	Levobunolol HydrochlorideANDA 74851	Alcon Labs Inc	12	Discontinued
Oct 29, 1996	AkbetaANDA 74779	Epic Pharma LLC	1	Discontinued
Oct 29, 1996	AkbetaANDA 74780	Epic Pharma LLC	1	Discontinued
Aug 3, 2000	Levobunolol HydrochlorideANDA 75473	Apotex Inc	2	Discontinued
Aug 3, 2000	Levobunolol HydrochlorideANDA 75475	Apotex Inc	2	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA