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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PROMETHAZINE W/ DEXTROMETHORPHAN

DEXTROMETHORPHAN HYDROBROMIDE
Respiratory Approved 1985-01-04
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1985-01-04
Routes
ORAL
Dosage Forms
SYRUP

Companies

PHARMOBEDIENT
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE , PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ DEXTROMETHORPHAN Approval History

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What PROMETHAZINE W/ DEXTROMETHORPHAN Treats

8 indications

PROMETHAZINE W/ DEXTROMETHORPHAN is approved for 8 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Common Cold
  • Nasal Congestion
  • Sinus Congestion
  • Cough
  • Minor Aches and Pains
  • Headache
  • Fever
  • Sore Throat
Source: FDA Label

Drugs Similar to PROMETHAZINE W/ DEXTROMETHORPHAN

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

IMMPHENTIV
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Shared indications:
CoughNasal CongestionSore Throat +2 more
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Shared indications:
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ADVAIR DISKUS 100/50
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1 shared
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Shared indications:
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1 shared
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Shared indications:
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Shared indications:
Nasal Congestion
ASTEPRO
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1 shared
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Shared indications:
Nasal Congestion
BREZTRI AEROSPHERE
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Shared indications:
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BUDESONIDE
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1 shared
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Shared indications:
Nasal Congestion
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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.

PROMETHAZINE W/ DEXTROMETHORPHAN FDA Label Details

Pro

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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Data Sources

FDA Approval: ANDA088864 → Label: DailyMed → Trials: ClinicalTrials.gov →

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