INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
Details
- Status
- Prescription
- First Approved
- 2001-02-21
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
Companies
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) Approval History
What INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) Treats
1 FDA approvalsOriginally approved for its first indication in 2001 .
- Other (1)
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.
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) FDA Label Details
ProIndications & Usage
FDA Label (PDF)Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 pp...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.