VIBISONE
Details
- Status
- Prescription
- First Approved
- 1973-06-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VIBISONE Approval History
What VIBISONE Treats
1 indicationsVIBISONE is approved for 1 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nutritional Deficiency
VIBISONE Boxed Warning
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately....
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
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.
VIBISONE FDA Label Details
ProIndications & Usage
INDICATIONS: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.