MEPHYTON (phytonadione) · BAUSCH
MEPHYTON is FDA-approved to treat 10 conditions (same as VITAMIN K1).
Details
- Status
- Discontinued
- First Approved
- 1955-09-30
- Routes
- ORAL
- Dosage Forms
- TABLET
MEPHYTON Approval History
What MEPHYTON Treats
10 indicationsMEPHYTON is approved for 10 conditions since its original approval in 1955. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coagulation Disorder
- Hypoprothrombinemia
- Obstructive Jaundice
- Biliary Fistula
- Sprue
- Ulcerative Colitis
- Celiac Disease
- Cystic Fibrosis
- Regional Enteritis
- Vitamin K Deficiency Bleeding
Same approved indications as VITAMIN K1 (same active ingredient).
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.
MEPHYTON FDA Label Details
Indications & Usage
FDA Label (PDF)MEPHYTON is FDA-approved to treat 10 conditions — same approved indications as VITAMIN K1.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.