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FDA NDA · NDA021163
INFUVITE ADULT
multiple vitamins injection
Sponsor: SANDOZ CANADA INC
APPLICATION
NDA021163
TYPE
NDA
ORIGINAL APPROVAL
2000-05-18
LATEST ACTION
2024-11-06
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
INFUVITE ADULT · ReferencePrescription
ALPHA-TOCOPHEROL ACETATE 2 IU/ML, ASCORBIC ACID 40MG/ML, BIOTIN 12MCG/ML, CHOLECALCIFEROL 40 IU/ML, CYANOCOBALAMIN 1MCG/ML, DEXPANTHENOL 3MG/ML, FOLIC ACID 120MCG/ML, NIACINAMIDE 8MG/ML, PYRIDOXINE HYDROCHLORIDE 1.2MG/ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 0.72MG/ML, THIAMINE HYDROCHLORIDE 1.2MG/ML, VITAMIN A PALMITATE 660 IU/ML, VITAMIN K 30MCG/ML · SOLUTION · INTRAVENOUS
INFUVITE ADULT · ReferencePrescription
ALPHA-TOCOPHEROL ACETATE 2 IU/ML, ASCORBIC ACID 40MG/ML, BIOTIN 12MCG/ML, CHOLECALCIFEROL 40 IU/ML, CYANOCOBALAMIN 1MCG/ML, DEXPANTHENOL 3MG/ML, FOLIC ACID 120MCG/ML, NIACINAMIDE 8MG/ML, PYRIDOXINE HYDROCHLORIDE 1.2MG/ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 0.72MG/ML, THIAMINE HYDROCHLORIDE 1.2MG/ML, VITAMIN A PALMITATE 660 IU/ML, VITAMIN K 0.03MG/ML · SOLUTION · INTRAVENOUS
Approval history
2015-10-26Manufacturing (CMC) · Supplement 31 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 30 · standardAP
2014-09-04Manufacturing (CMC) · Supplement 29 · standardAP
2013-12-03Manufacturing (CMC) · Supplement 28 · standardAP
2013-09-04Manufacturing (CMC) · Supplement 25 · standardAP
2013-07-13Manufacturing (CMC) · Supplement 26 · standardAP
2006-08-22Manufacturing (CMC) · Supplement 14AP
2002-07-09Manufacturing (CMC) · Supplement 4 · standardAP
2001-06-26Manufacturing (CMC) · Supplement 3 · standardAP
2001-06-13Manufacturing (CMC) · Supplement 2 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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