Details for New Drug Application (NDA): 210671

NDA 210671 describes MULTIPLE VITAMINS INJECTION PEDIATRIC, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. Additional details are available on the MULTIPLE VITAMINS INJECTION PEDIATRIC profile page.

The generic ingredient in MULTIPLE VITAMINS INJECTION PEDIATRIC is ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k profile page.

Summary for 210671

Tradename:	MULTIPLE VITAMINS INJECTION PEDIATRIC
Applicant:	Apotex
Ingredient:	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k
Patents:	0

Suppliers and Packaging for NDA: 210671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MULTIPLE VITAMINS INJECTION PEDIATRIC	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	210671	ANDA	Apotex Corp.	60505-6190	60505-6190-0	1 KIT in 1 CARTON (60505-6190-0) * 4 mL in 1 VIAL (60505-6297-1) * 1 mL in 1 VIAL (60505-6298-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	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
Approval Date:	Apr 21, 2026	TE:	AP	RLD:	No

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