Drug application
INFUVITE PEDIATRIC (ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL and 10 more)
Drugs@FDA NDA 021265 · SANDOZ CANADA INC
Key facts
| Drug name | INFUVITE PEDIATRIC |
|---|---|
| Active ingredients | ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, DEXPANTHENOL, FOLIC ACID, NIACINAMIDE, PYRIDOXINE, RIBOFLAVIN, THIAMINE, TOCOPHEROL ACETATE, VITAMIN A and 1 more |
| Application type | NDA |
| Application number | 021265 |
| Company | SANDOZ CANADA INC |
| Dosage forms | INJECTABLE, INTRAVENOUS |
| Strength | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Feb 21, 2001 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: