TheraRadar
Data updated: Nov 8, 2026

VELTANE (brompheniramine maleate) · LANNETT CO INC

Respiratory Approved 1974-05-17
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1974-05-17
Routes
Oral
Dosage Forms
Tablet

Companies

LANNETT CO INC
Active Ingredient: BROMPHENIRAMINE MALEATE

VELTANE Approval History

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Original
New Indication
New Form
Label Update
1 FDA actions from 1974 to 1974
May 1974 ORIGINAL
Update

What VELTANE Treats

1 FDA approvals

Originally approved for its first indication in 1974 .

  • Other (1)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00894634 BF-08-06 Ph 1 completed Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents
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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.

VELTANE FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

FDA Approval: ANDA084088 → Trials: ClinicalTrials.gov →

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