TheraRadar
Data updated: May 26, 2026

POLMON (dexchlorpheniramine maleate)

Respiratory Approved 2018-07-16

POLMON is indicated for the treatment of Allergic Rhinitis; Upper Respiratory Allergy; Cough.

Source: FDA Label • PHARMOBEDIENT
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-07-16
Routes
ORAL
Dosage Forms
SYRUP

Companies

PHARMOBEDIENT
Active Ingredient: DEXCHLORPHENIRAMINE MALEATE

POLMON Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2018 to 2018
Jul 2018 ORIGINAL
Update

What POLMON Treats

3 indications

POLMON is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Rhinitis
  • Upper Respiratory Allergy
  • Cough
Source: FDA Label

POLMON Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dr. Reddy's
2025 8 indic.
LEVOCETIRIZINE HYDROCHLORIDE
HETERO LABS
2019 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to POLMON

3 of 20

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

TUXARIN ER
CHLORPHENIRAMINE MALEATE
2 shared
MAINPOINTE
Shared indications:
Allergic RhinitisUpper Respiratory Allergy
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
1 shared
GSK
Shared indications:
Upper Respiratory Allergy
ASTEPRO
AZELASTINE HYDROCHLORIDE
1 shared
Viatris
Shared indications:
Upper Respiratory Allergy
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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.

POLMON FDA Label Details

Indications & Usage

POLMON is indicated for the treatment of Allergic Rhinitis; Upper Respiratory Allergy; Cough.

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Data Sources

FDA Approval: ANDA202520 → Label: DailyMed → Trials: ClinicalTrials.gov →

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