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Data updated: May 26, 2026

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (dorzolamide hydrochloride)

Genetically Validated
Ophthalmology Approved 2008-10-28

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is indicated for the treatment of Glaucoma; Ocular Hypertension.

19
Indications
--
Phase 3 Trials
17
Years on Market

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Approval History

2009
2010
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2015
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2026
Original
New Indication
New Form
Label Update
50 FDA actions from 2008 to 2025
Sep 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Label · Labeling

What DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Treats

2 indications

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Glaucoma
  • Ocular Hypertension
Source: FDA Label

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Target & Pathway

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DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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.

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE FDA Label Details

Indications & Usage

FDA Label (PDF)

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is indicated for the treatment of Glaucoma; Ocular Hypertension.

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Data Sources

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