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FDA ANDA · ANDA210671

MULTIPLE VITAMINS (PEDIATRIC) SINGLE DOSE VIAL

ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin-5 phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin

Sponsor: APOTEX

APPLICATION
ANDA210671
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-21
LATEST ACTION
2026-04-21
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MULTIPLE VITAMINS INJECTION PEDIATRICPrescription
ASCORBIC ACID 80MG/VIAL, BIOTIN 0.02MG/VIAL, CHOLECALCIFEROL 400 IU/VIAL, CYANOCOBALAMIN 0.001MG/VIAL, DEXPANTHENOL 5MG/VIAL, FOLIC ACID 0.14MG/VIAL, NIACINAMIDE 17MG/VIAL, PYRIDOXINE 1MG/VIAL, RIBOFLAVIN 1.4MG/VIAL, THIAMINE 1.2MG/VIAL, TOCOPHEROL ACETATE 7 IU/VIAL, VITAMIN A 2,300 IU/VIAL, VITAMIN K 0.2MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2026-04-21UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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