TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

EPINEPHRINE BITARTRATE
Approved 2025-02-28
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2025-02-28
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: EPINEPHRINE BITARTRATE

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Approval History

Loading approval history...

What EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
πŸ”¬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
πŸ“Š

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.

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older. Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older .

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

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