TheraRadar
Data updated: May 26, 2026

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (chlorpheniramine maleate)

Respiratory Approved 2014-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2014-04-29
Routes
ORAL
Dosage Forms
SOLUTION

Companies

TRIS PHARMA INC MAYNE PHARMA INC PADAGIS US SCIEGEN PHARMS
Active Ingredient: CHLORPHENIRAMINE MALEATE , HYDROCODONE BITARTRATE , PSEUDOEPHEDRINE HYDROCHLORIDE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2014 to 2025
Apr 2025 SUPPL
Label · Labeling
Dec 2023 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label · Labeling

What HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE Treats

4 FDA approvals

Originally approved for its first indication in 2014 . Covers 4 distinct patient populations.

  • Other (4)
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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.

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA203838 → Trials: ClinicalTrials.gov →

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