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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE
Approved 2012-12-20
27
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

PHENYLEPHRINE HYDROCHLORIDE Approval History

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What PHENYLEPHRINE HYDROCHLORIDE Treats

1 indications

PHENYLEPHRINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
Source: FDA Label

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Key Completed Trials

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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.

PHENYLEPHRINE HYDROCHLORIDE FDA Label Details

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Indications & 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

Latest Patent: Sep 2036

Patents (22 active)

US11213480 Expires Sep 26, 2036
US12257342 Expires Sep 26, 2036
US11471400 Expires Aug 5, 2036
US8859623 Expires Nov 14, 2033
+ 12 more patents
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.