FDA.reportPublic FDA data

Application 021265

Type
NDA
Sponsor
SANDOZ CANADA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFUVITE PEDIATRICASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN KINJECTABLE;INTRAVENOUS80MG/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/VIALYesYes
002INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL HYDROCHLORIDE; VITAMIN A; VITAMIN KINJECTABLE;INTRAVENOUS80MG/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/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54643-5646Pediatric Infuvite Multiple Vitamins for InfusionAsorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, FoSandoz Canada IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz IncNDACurrent
54643-5646PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSIONascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalaminSandoz Manufacturing IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-7886Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz Manufacturing IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz IncNDACurrent
54643-9023Pediatric Infuvite Multiple VitaminsAscorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, CyanocobalaminSandoz Manufacturing IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80178SUPPL 2025-02-04
80179SUPPL 2024-11-07
36505SUPPL2016-03-22
4827SUPPL2016-03-21
14783SUPPL2009-01-02
27264SUPPL2008-12-23
4826SUPPL2004-06-07
14782SUPPL2003-05-02
36504ORIG2001-02-21
21555ORIG2001-02-21
4825ORIG2001-02-21