BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (brompheniramine maleate) · Dr. Reddy's
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Details
- Status
- Prescription
- First Approved
- 2014-07-15
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Approval History
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.