Data updated: May 26, 2026
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE (dexbrompheniramine maleate)
Respiratory
Approved 2013-02-27
1
Indication
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-02-27
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2013 to 2013
What DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.