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Generated: September 24, 2018

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Details for New Drug Application (NDA): 021646

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NDA 021646 describes INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), which is a drug marketed by Sandoz Inc and is included in one NDA. It is available from one supplier. Additional details are available on the INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) profile page.

The generic ingredient in INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) 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. One supplier is 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.
Suppliers and Packaging for NDA: 021646
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021646 NDA Sandoz Canada Inc 54643-5647 54643-5647-0 1 KIT in 1 CARTON (54643-5647-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021646 NDA Sandoz Canada Inc 54643-7898 54643-7898-0 1 KIT in 1 CARTON (54643-7898-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength80MG/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:Jan 29, 2004TE:RLD:Yes

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