LOMOTIL
Details
- Status
- Prescription
- First Approved
- 1960-09-15
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
Companies
LOMOTIL Approval History
What LOMOTIL Treats
1 indicationsLOMOTIL is approved for 1 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diarrhea
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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.
LOMOTIL FDA Label Details
ProIndications & Usage
FDA Label (PDF)Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.