01 2ORGANON LLC
02 4SANDOZ CANADA INC
01 2INJECTABLE;INTRAVENOUS
02 2SOLUTION;INTRAVENOUS
03 2TABLET;ORAL
01 6RX
01 2FOSAMAX PLUS D
02 2INFUVITE ADULT
03 1INFUVITE PEDIATRIC
04 1INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
01 6Yes
RLD : Yes
TE Code :
ALENDRONATE SODIUM; CHOLECALCIFEROL
Brand Name : FOSAMAX PLUS D
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 70MG BASE;2,800 IU
Approval Date : 2005-04-07
Application Number : 21762
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ALENDRONATE SODIUM; CHOLECALCIFEROL
Brand Name : FOSAMAX PLUS D
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 70MG BASE;5,600 IU
Approval Date : 2007-04-26
Application Number : 21762
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
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
Brand Name : INFUVITE ADULT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
Approval Date : 2000-05-18
Application Number : 21163
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
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
Brand Name : INFUVITE ADULT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
Approval Date : 2003-06-16
Application Number : 21163
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
Brand Name : INFUVITE PEDIATRIC
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage 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 : 2001-02-21
Application Number : 21265
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
Brand Name : INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage 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 : 2004-01-29
Application Number : 21265
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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