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Data updated: Mar 10, 2026

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE
Respiratory Approved 2009-08-25
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-08-25
Routes
ORAL
Dosage Forms
SYRUP

Companies

AMNEAL PHARMS
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE , PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Approval History

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What PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Treats

4 indications

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Upper Respiratory Symptoms
  • Nasal Congestion
  • Allergy
  • Common Cold
Source: FDA Label

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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.

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE FDA Label Details

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Indications & Usage

Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

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Data Sources

FDA Approval: ANDA040902 → Label: DailyMed → Trials: ClinicalTrials.gov →

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