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Data updated: May 26, 2026

VELTANE (brompheniramine maleate)

Respiratory Approved 1974-05-17

VELTANE is indicated for the treatment of Runny Nose; Sneezing; Itchy Eyes; Hay Fever; Itching.

Source: FDA Label • LANNETT
Jump to: Indications Approvals Trials Competitors Similar 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
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

5 indications

VELTANE is approved for 5 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Runny Nose
  • Sneezing
  • Itchy Eyes
  • Hay Fever
  • Itching
Source: FDA Label

VELTANE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dr. Reddy's
2025 8 indic.
LIVMARLI
MIRUM
2021 3 indic.
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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.

Drugs Similar to VELTANE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ADVAIR DISKUS 100/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Hay FeverRunny NoseSneezing
ADVAIR DISKUS 250/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Hay FeverRunny NoseSneezing
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
3 shared
GSK
Shared indications:
Hay FeverRunny NoseSneezing
View all 20 similar drugs Pro
📋

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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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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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

Indications & Usage

VELTANE is indicated for the treatment of Runny Nose; Sneezing; Itchy Eyes; Hay Fever; Itching.

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Data Sources

FDA Approval: ANDA084088 → Label: DailyMed → Trials: ClinicalTrials.gov →

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