PROPARACAINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 1974-11-01
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
PROPARACAINE HYDROCHLORIDE Approval History
What PROPARACAINE HYDROCHLORIDE Treats
7 FDA approvalsOriginally approved for its first indication in 1974 . Covers 7 distinct patient populations.
- Other (7)
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.
PROPARACAINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.