Data updated: Mar 10, 2026
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
BROMPHENIRAMINE MALEATE
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
TARO CHARTWELL MOLECULAR RHODES PHARMS PHARM ASSOC BIONPHARMA Dr. Reddy's ACELLA HIBROW HLTHCARE ALKEM LABS LTD PADAGIS US
Active Ingredient: BROMPHENIRAMINE MALEATE , DEXTROMETHORPHAN HYDROBROMIDE , PSEUDOEPHEDRINE HYDROCHLORIDE
Website: ↗
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Approval History
Loading 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)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.