Drug application
INFUVITE ADULT (ALPHA-TOCOPHEROL ACETATE, ASCORBIC ACID, BIOTIN and 10 more)
Drugs@FDA NDA 021163 · SANDOZ CANADA INC
Key facts
| Drug name | INFUVITE ADULT |
|---|---|
| Active ingredients | ALPHA-TOCOPHEROL ACETATE, ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, DEXPANTHENOL, FOLIC ACID, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN 5'-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, VITAMIN A PALMITATE and 1 more |
| Application type | NDA |
| Application number | 021163 |
| Company | SANDOZ CANADA INC |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | May 18, 2000 |
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: