TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ZONISAMIDE

ZONISAMIDE
Approved 2005-12-22
Jump to: Indications Approvals Trials Competitors Safety Patents
10
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2005-12-22
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Sun Pharma GLENMARK PHARMS INC UPSHER SMITH LABS INVAGEN PHARMS GRANULES ANI PHARMS Aurobindo Pharma PHARMOBEDIENT EPIC PHARMA LLC Apotex CHARTWELL RX ZYDUS LIFESCIENCES MACLEODS PHARMS LTD RISING UNICHEM ROXANE BIONPHARMA
Active Ingredient: ZONISAMIDE

ZONISAMIDE Approval History

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What ZONISAMIDE Treats

10 FDA approvals

Originally approved for its first indication in 2005 . Covers 10 distinct patient populations.

  • Other (10)
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Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

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.

ZONISAMIDE FDA Label Details

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Data Sources

FDA Approval: ANDA077634 → Trials: ClinicalTrials.gov →

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