EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (epinephrine bitartrate)
This medication helps patients manage pain during dental procedures by providing local, infiltrative, or conductive anesthesia. It is used for both simple and complex dental work in adults and children four years of age and older. The combination of a local anesthetic and a vasoconstrictor ensures that the numbing effect remains concentrated where it is needed during the procedure.
How EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Works
This drug works by blocking the generation and conduction of nerve impulses, which prevents pain signals from traveling along the nerve fibers. The addition of epinephrine narrows blood vessels to slow the absorption of the anesthetic into the bloodstream, which helps maintain the medication's presence in the local tissue for a longer duration.
Details
- Status
- Prescription
- First Approved
- 2025-02-28
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Approval History
What EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Treats
5 indicationsEPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is approved for 5 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Simple dental procedures
- Complex dental procedures
- Local anesthesia
- Infiltrative anesthesia
- Conductive anesthesia
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Competitive Set
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Trial Timeline
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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.
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Simple dental procedures; Complex dental procedures; Local anesthesia; Infiltrative anesthesia; Conductive anesthesia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.