DYCLOPRO
Details
- Status
- Prescription
- First Approved
- 2018-11-20
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION
DYCLOPRO Approval History
What DYCLOPRO Treats
3 indicationsDYCLOPRO is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Oral Ulcers
- Stomatitis
- Ano-Genital Lesions
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.
DYCLOPRO FDA Label Details
ProIndications & Usage
: Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.