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Data updated: Mar 10, 2026

CARBINOXAMINE MALEATE

CARBINOXAMINE MALEATE
Dermatology Approved 2003-03-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
10
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-03-19
Routes
ORAL
Dosage Forms
TABLET, SOLUTION

Companies

MIKART LEADING SENORES PHARMS GENUS MISSION PHARMACAL CYPRESS PHARM STRIDES PHARMA INTL PH HEALTH
Active Ingredient: CARBINOXAMINE MALEATE

CARBINOXAMINE MALEATE Approval History

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What CARBINOXAMINE MALEATE Treats

7 indications

CARBINOXAMINE MALEATE is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Rhinitis
  • Vasomotor Rhinitis
  • Allergic Conjunctivitis
  • Urticaria
  • Angioedema
  • Dermatographism
  • Anaphylactic Reaction
Source: FDA Label

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Shared indications:
Allergic Conjunctivitis
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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.

CARBINOXAMINE MALEATE FDA Label Details

Pro

Indications & Usage

Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.

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Data Sources

FDA Approval: ANDA207484 → Label: DailyMed → Trials: ClinicalTrials.gov →

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