Data updated: May 26, 2026
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (brompheniramine maleate)
Pain
Approved 2014-07-15
10
Indications
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-07-15
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
RHODES PHARMS ACELLA Dr. Reddy's HIBROW HLTHCARE BIONPHARMA CHARTWELL MOLECULAR TARO PHARM ASSOC ALKEM LABS LTD PADAGIS US
Active Ingredient: BROMPHENIRAMINE MALEATE , DEXTROMETHORPHAN HYDROBROMIDE , PSEUDOEPHEDRINE HYDROCHLORIDE
Website: ↗
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2014 to 2023
May 2023 SUPPL
Label · Labeling
Oct 2022 SUPPL
Label · Labeling
Nov 2020 ORIGINAL
Update
Sep 2020 ORIGINAL
Update
Jul 2020 ORIGINAL
Update
Jun 2020 ORIGINAL
Update
Apr 2020 ORIGINAL
Update
Dec 2018 ORIGINAL
Update
Feb 2017 ORIGINAL
Update
Sep 2016 ORIGINAL
Update
Jul 2014 ORIGINAL
Update
Jul 2014 ORIGINAL
Update
What BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Treats
10 FDA approvalsOriginally approved for its first indication in 2014 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Jul 2014)
- • Approved indication (Jul 2014)
- • Approved indication (Sep 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Dec 2018)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Nov 2020)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00894634 | BF-08-06 | Ph 1 | completed | Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents |
🔬
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.
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.