TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

SEPTOCAINE

ARTICAINE HYDROCHLORIDE
Approved 2000-04-03
2
Indications
--
Phase 3 Trials
25
Years on Market

Details

Status
Prescription
First Approved
2000-04-03
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

SEPTOCAINE Approval History

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What SEPTOCAINE Treats

2 FDA approvals

Originally approved for its first indication in 2000 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

SEPTOCAINE FDA Label Details

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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 .

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Data Sources

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