alpha Tocopherol / Ascorbic Acid / Biotin / Cholecalciferol / dexpanthenol / Folic Acid / Niacinamide / pyridoxine / Riboflavin / Thiamine / Vitamin A / Vitamin B 12 / Vitamin K 1 Injectable Solution

Brand(s)
Infuvite, Infuvite Pediatric
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Canada Inc (2014-07-14)
Oldest Current Product
2004-01-29
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\ALPHA TOCOPHEROL:ASCORBIC ACID:BIOTIN:CHOLECALCIFEROL:DEXPANTHENOL:FOLIC ACID:NIACINAMIDE:PYRIDOXINE:RIBOFLAVIN:THIAMINE:VITAMIN A:VITAMIN B 12:VITAMIN K 1
FDAOB
INJECTION\INJECTION\ALPHA-TOCOPHEROL ACETATE: ASCORBIC ACID: BIOTIN: CHOLECALCIFEROL: CYANOCOBALAMIN: DEXPANTHENOL: FOLIC ACID: NIACINAMIDE: PYRIDOXINE HYDROCHLORIDE: RIBOFLAVIN 5'-PHOSPHATE SODIUM: THIAMINE HYDROCHLORIDE: VITAMIN A PALMITATE: VITAMIN K\rdfq
IV (INFUSION)\INJECTION\ALPHA-TOCOPHEROL ACETATE: ASCORBIC ACID: BIOTIN: CHOLECALCIFEROL: CYANOCOBALAMIN: DEXPANTHENOL: FOLIC ACID: NIACINAMIDE: PYRIDOXINE HYDROCHLORIDE: RIBOFLAVIN 5'-PHOSPHATE SODIUM: THIAMINE HYDROCHLORIDE: VITAMIN A PALMITATE: VITAMIN K\rdfq
IV (INFUSION)\INJECTION\ASCORBIC ACID: BIOTIN: CHOLECALCIFEROL: CYANOCOBALAMIN: DEXPANTHENOL: FOLIC ACID: NIACINAMIDE: PYRIDOXINE: RIBOFLAVIN: THIAMINE: TOCOPHEROL ACETATE: VITAMIN A: VITAMIN K\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\.ALPHA.-TOCOPHEROL ACETATE: ASCORBIC ACID: BIOTIN: CHOLECALCIFEROL: CYANOCOBALAMIN: DEXPANTHENOL: FOLIC ACID: NIACINAMIDE: PHYTONADIONE: PYRIDOXINE HYDROCHLORIDE: RIBOFLAVIN 5'-PHOSPHATE SODIUM: THIAMINE HYDROCHLORIDE: VITAMIN A PALMITATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\.ALPHA.-TOCOPHEROL: ASCORBIC ACID: BIOTIN: CHOLECALCIFEROL: CYANOCOBALAMIN: DEXPANTHENOL: FOLIC ACID: NIACINAMIDE: PHYTONADIONE: PYRIDOXINE: RIBOFLAVIN: THIAMINE: VITAMIN A

product(s) by strength(s)

alpha-tocopherol acetate 1 unt/ml / ascorbic acid 20 mg/ml / biotin 0.006 mg/ml / cholecalciferol 20 unt/ml / dexpanthenol 1.5 mg/ml / folic acid 0.06 mg/ml / niacinamide 4 mg/ml / pyridoxine hydrochloride 0.6 mg/ml / retinyl palmitate 330 unt/ml / riboflavin 0.36 mg/ml / thiamine hydrochloride 0.6 mg/ml / vitamin b 12 0.0005 mg/ml / vitamin k 1 0.015 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1546435649InfuviteNDASandoz Canada Inc2005-05-18.ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, DEXPANTHENOL, FOLIC ACID, NIACINAMIDE, PHYTONADIONE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN 5'-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, VITAMIN A PALMITATEINTRAVENOUSINJECTION, SOLUTIONNDA02116359754e70-d6d1-4738-8ba7-b8e2bc959dcf

alpha-tocopherol acetate 1.4 unt/ml / ascorbic acid 16 mg/ml / biotin 0.004 mg/ml / cholecalciferol 80 unt/ml / dexpanthenol 1 mg/ml / folic acid 0.028 mg/ml / niacinamide 3.4 mg/ml / pyridoxine hydrochloride 0.2 mg/ml / retinyl palmitate 460 unt/ml / riboflavin 0.28 mg/ml / thiamine hydrochloride 0.24 mg/ml / vitamin b 12 0.0002 mg/ml / vitamin k 1 0.04 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1546435647Infuvite PediatricNDASandoz Canada Inc2004-01-29.ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, DEXPANTHENOL, FOLIC ACID, NIACINAMIDE, PHYTONADIONE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN 5'-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, VITAMIN A PALMITATEKITNDA0216466d06546e-8b0a-4490-82d9-397bd902a044

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021163INFUVITE ADULTSANDOZ CANADA INC2000-05-18NDA021163_001
2NDA021265INFUVITE PEDIATRICSANDOZ CANADA INC2001-02-21NDA021265_001
3NDA021559INFUVITE ADULTSANDOZ CANADA INC2003-06-16NDA021559_001
4NDA021646INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)SANDOZ CANADA INC2004-01-29NDA021646_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021163_001RXVITAMIN A PALMITATE (660 IU/ML), THIAMINE HYDROCHLORIDE (1.2MG/ML), CYANOCOBALAMIN (1MCG/ML), DEXPANTHENOL (3MG/ML), NIACINAMIDE (8MG/ML), BIOTIN (12MCG/ML), ASCORBIC ACID (40MG/ML), CHOLECALCIFEROL (40 IU/ML), ALPHA-TOCOPHEROL ACETATE (2 IU/ML), RIBOFLAVIN 5'-PHOSPHATE SODIUM (0.72MG/ML), PYRIDOXINE HYDROCHLORIDE (1.2MG/ML), FOLIC ACID (120MCG/ML), VITAMIN K (0.03MG/ML)INJECTIONTrue2000-05-18INFUVITE ADULT
2NDA021265_001RXBIOTIN (0.02MG/VIAL), CHOLECALCIFEROL (400 IU/VIAL), ASCORBIC ACID (80MG/VIAL), VITAMIN K (0.2MG/VIAL), FOLIC ACID (0.14MG/VIAL), VITAMIN A (2,300 IU/VIAL), NIACINAMIDE (17MG/VIAL), TOCOPHEROL ACETATE (7 IU/VIAL), CYANOCOBALAMIN (0.001MG/VIAL), THIAMINE (1.2MG/VIAL), DEXPANTHENOL (5MG/VIAL), PYRIDOXINE (1MG/VIAL), RIBOFLAVIN (1.4MG/VIAL)INJECTIONTrue2001-02-21INFUVITE PEDIATRIC
3NDA021559_001RXVITAMIN K (30MCG/ML), VITAMIN A PALMITATE (660 IU/ML), THIAMINE HYDROCHLORIDE (1.2MG/ML), ALPHA-TOCOPHEROL ACETATE (2 IU/ML), ASCORBIC ACID (40MG/ML), DEXPANTHENOL (3MG/ML), CYANOCOBALAMIN (1MCG/ML), CHOLECALCIFEROL (40 IU/ML), BIOTIN (12MCG/ML), RIBOFLAVIN 5'-PHOSPHATE SODIUM (0.72MG/ML), PYRIDOXINE HYDROCHLORIDE (1.2MG/ML), NIACINAMIDE (8MG/ML), FOLIC ACID (120MCG/ML)INJECTIONTrue2003-06-16INFUVITE ADULT
4NDA021646_001RXDEXPANTHENOL (5MG/VIAL), PYRIDOXINE (1MG/VIAL), NIACINAMIDE (17MG/VIAL), THIAMINE (1.2MG/VIAL), RIBOFLAVIN (1.4MG/VIAL), VITAMIN A (2,300 IU/VIAL), TOCOPHEROL ACETATE (7 IU/VIAL), FOLIC ACID (0.14MG/VIAL), CHOLECALCIFEROL (400 IU/VIAL), VITAMIN K (0.2MG/VIAL), CYANOCOBALAMIN (0.001MG/VIAL), ASCORBIC ACID (80MG/VIAL), BIOTIN (0.02MG/VIAL)INJECTIONTrue2004-01-29INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
114c7bfc5-07e8-400f-b8ff-5e4794dd2805 (view SPL)These highlights do not include all the information needed to use INFUVITE ADULT (PHARMACY BULK PACKAGE) safely and effectively. See full prescribing information for INFUVITE ADULT (PHARMACY BULK PACKAGE).INFUVITE ADULT PHARMACY BULK PACKAGEInitial U.S. Approval: 2003prescriptionHuman PrescriptionSandoz Canada Inc2013-01-0112546435650
22e3c2e71-a3b8-48bf-8e95-96299424cad5 (view SPL)INFUVITE PEDIATRIC -multiple vitamins for infusionprescriptionHuman PrescriptionSandoz Canada Inc2012-01-2410546435646
359754e70-d6d1-4738-8ba7-b8e2bc959dcf (view SPL)INFUVITE ADULTMultiple Vitamins for InfusionprescriptionHuman PrescriptionSandoz Canada Inc2012-01-2410546435649
46d06546e-8b0a-4490-82d9-397bd902a044 (view SPL)These highlights do not include all the information needed to use INFUVITE PEDIATRIC safely and effectively. See full prescribing information for INFUVITE PEDIATRIC.INFUVITE PEDIATRIC (multiple vitamins injection), for intravenous useInitial U.S. Approval: 2004prescriptionHuman PrescriptionSandoz Canada Inc2014-07-1413546435647

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII