TROPICACYL (tropicamide)
TROPICACYL is indicated for the treatment of Mydriasis; Cycloplegia.
Details
- Status
- Prescription
- First Approved
- 2000-09-29
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
TROPICACYL Approval History
What TROPICACYL Treats
2 indicationsTROPICACYL is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mydriasis
- Cycloplegia
TROPICACYL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03959176 results posted | IRB00058366 | Ph 4 | completed | The Effect of Brimonidine |
| NCT05238233 results posted | 1864081 | Ph 4 | completed | Wearing-Off Period of Pharmacological Dilation and Anisocoria |
| NCT05442801 | Cycloplegic Refraction | Ph 4 | completed | Cycloplegic Refraction Among Children |
| NCT03139708 | IRB00039213 | Ph 1 | completed | The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients |
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.
TROPICACYL FDA Label Details
Indications & Usage
TROPICACYL is indicated for the treatment of Mydriasis; Cycloplegia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.