TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BENZONATATE

BENZONATATE
Approved 1993-01-29
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Discontinued
First Approved
1993-01-29
Routes
ORAL
Dosage Forms
CAPSULE

Companies

CHARTWELL RX Sun Pharma THEPHARMANETWORK LLC BIONPHARMA ZYDUS PHARMS USA MIKART NESHER PHARMS PURACAP PHARM LLC HERITAGE PHARMS LABS ONESOURCE SPECIALTY ACELLA CSPC-NBP PHARM ASCENT PHARMS INC
Active Ingredient: BENZONATATE

BENZONATATE Approval History

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What BENZONATATE Treats

15 FDA approvals

Originally approved for its first indication in 1993 . Covers 15 distinct patient populations.

  • Other (15)
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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.

BENZONATATE FDA Label Details

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Data Sources

FDA Approval: ANDA210562 → Trials: ClinicalTrials.gov →

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