MARCAINE
Details
- Status
- Prescription
- First Approved
- 1984-05-04
- Routes
- SPINAL
- Dosage Forms
- INJECTABLE
MARCAINE Approval History
What MARCAINE Treats
1 FDA approvalsOriginally approved for its first indication in 1984 .
- Other (1)
Other
(1 approval)- • Approved indication (May 1984)
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.
MARCAINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults. Marcaine® 0.5% (5 mg/mL) with epinephrine 1:200,000 injection is not recommended for children.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.