FdaApplication
ANDA 210456
Identifiers
- fda_app_no: ANDA210456
Properties
| Property | Value |
|---|---|
| applicant_name | APOTEX INC |
| application_type | ANDA |
| approval_date | 2026-04-21 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 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 | INJECTABLE;INTRAVENOUS |
1 product