TheraRadar
Data updated: May 26, 2026

VITUZ (chlorpheniramine maleate)

Respiratory Approved 2013-02-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2013-02-20
Routes
ORAL
Dosage Forms
SOLUTION

Companies

PERSION
Active Ingredient: CHLORPHENIRAMINE MALEATE , HYDROCODONE BITARTRATE

VITUZ Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2013 to 2018
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label
Jan 2017 SUPPL
Label · Labeling
FDA Letter Label
Feb 2013 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What VITUZ Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

VITUZ FDA Label Details

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Data Sources

FDA Approval: NDA204307 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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