PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE (phenylephrine hydrochloride)
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is indicated for the treatment of Upper Respiratory Symptoms; Nasal Congestion; Allergy; Common Cold.
Details
- Status
- Prescription
- First Approved
- 2009-08-25
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Approval History
What PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Treats
4 indicationsPROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Upper Respiratory Symptoms
- Nasal Congestion
- Allergy
- Common Cold
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
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.
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE FDA Label Details
Indications & Usage
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE is indicated for the treatment of Upper Respiratory Symptoms; Nasal Congestion; Allergy; Common Cold.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.