What is TOLAZAMIDE used for?

TOLAZAMIDE is an FDA-approved medication. See full prescribing information for approved uses.

Is TOLAZAMIDE FDA approved?

Yes, TOLAZAMIDE is FDA approved (first approved 1984-10-03) and manufactured by WATSON LABS.

Who makes TOLAZAMIDE?

TOLAZAMIDE is manufactured by WATSON LABS.

Data updated: Mar 10, 2026

TOLAZAMIDE

Approved 1984-10-03

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1984-10-03
Routes: ORAL
Dosage Forms: TABLET

Companies

WATSON LABS Sun Pharma PAR PHARM USL PHARMA INTERPHARM CHARTWELL RX DURAMED PHARMS BARR COSETTE SUPERPHARM Teva NATCO

Active Ingredient: TOLAZAMIDE

TOLAZAMIDE Approval History

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What TOLAZAMIDE Treats

10 FDA approvals

Originally approved for its first indication in 1984 . 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

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.

TOLAZAMIDE FDA Label Details

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Data Sources

FDA Approval: ANDA070514 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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