DYCLOPRO (dyclonine hydrochloride)
DYCLOPRO is indicated for the treatment of Oral Ulcers; Stomatitis; Ano-Genital Lesions.
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
Indications & Usage
DYCLOPRO is indicated for the treatment of Oral Ulcers; Stomatitis; Ano-Genital Lesions.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.