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Data updated: Mar 10, 2026

TIMOPTIC IN OCUDOSE

TIMOLOL MALEATE
Cardiovascular Approved 1986-11-05
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-11-05
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

BAUSCH AND LOMB INC
Active Ingredient: TIMOLOL MALEATE

TIMOPTIC IN OCUDOSE Approval History

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What TIMOPTIC IN OCUDOSE Treats

2 indications

TIMOPTIC IN OCUDOSE is approved for 2 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ocular Hypertension
  • Open-Angle Glaucoma
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TIMOPTIC IN OCUDOSE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Preservative-free TIMOPTIC in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free TIMOPTIC in OCUDOSE may be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

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Data Sources

FDA Approval: NDA019463 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.