PREPIDIL
Details
- Status
- Prescription
- First Approved
- 1992-12-09
- Routes
- ENDOCERVICAL
- Dosage Forms
- GEL
PREPIDIL Approval History
What PREPIDIL Treats
1 indicationsPREPIDIL is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unfavorable Cervix
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.
PREPIDIL FDA Label Details
ProIndications & Usage
FDA Label (PDF)PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.