PHENYLEPHRINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2012-12-20
- Routes
- INTRAVENOUS, OPHTHALMIC
- Dosage Forms
- SOLUTION, SOLUTION/DROPS
PHENYLEPHRINE HYDROCHLORIDE Approval History
What PHENYLEPHRINE HYDROCHLORIDE Treats
1 indicationsPHENYLEPHRINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
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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.
PHENYLEPHRINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)1 INDICATIONS & USAGE Phenylephrine hydrochloride Injection, 10 mg/mL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
PHENYLEPHRINE HYDROCHLORIDE Patents & Exclusivity
Patents (22 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.