Data updated: May 26, 2026
CITANEST PLAIN DENTAL (prilocaine hydrochloride)
Other
Approved 1965-11-18
1
Indication
--
Phase 3 Trials
60
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1965-11-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CITANEST PLAIN DENTAL Approval History
1966
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Original
New Indication
New Form
Label Update
2 FDA actions from 1965 to 2018
Nov 1965 ORIGINAL
Update
What CITANEST PLAIN DENTAL Treats
1 FDA approvalsOriginally approved for its first indication in 1965 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 1965)
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Pro 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.
CITANEST PLAIN DENTAL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.