← FDA DRUG APPROVALS

FDA NDA · NDA021265

INFUVITE PEDIATRIC

multiple vitamins injection

Sponsor: SANDOZ CANADA INC

APPLICATION
NDA021265
TYPE
NDA
ORIGINAL APPROVAL
2001-02-21
LATEST ACTION
2024-11-06
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) · ReferencePrescription
ASCORBIC ACID 80MG/VIAL, BIOTIN 0.02MG/VIAL, CHOLECALCIFEROL 400 IU/VIAL, CYANOCOBALAMIN 0.001MG/VIAL, DEXPANTHENOL 5MG/VIAL, FOLIC ACID 0.14MG/VIAL, NIACINAMIDE 17MG/VIAL, PYRIDOXINE 1MG/VIAL, RIBOFLAVIN 1.4MG/VIAL, THIAMINE 1.2MG/VIAL, TOCOPHEROL ACETATE 7 IU/VIAL, VITAMIN A 2,300 IU/VIAL, VITAMIN K 0.2MG/VIAL · INJECTABLE · INTRAVENOUS
INFUVITE PEDIATRIC · ReferencePrescription
ASCORBIC ACID 80MG/VIAL, BIOTIN 0.02MG/VIAL, CHOLECALCIFEROL 400 IU/VIAL, CYANOCOBALAMIN 0.001MG/VIAL, DEXPANTHENOL 5MG/VIAL, FOLIC ACID 0.14MG/VIAL, NIACINAMIDE 17MG/VIAL, PYRIDOXINE 1MG/VIAL, RIBOFLAVIN 1.4MG/VIAL, THIAMINE 1.2MG/VIAL, TOCOPHEROL ACETATE 7 IU/VIAL, VITAMIN A 2,300 IU/VIAL, VITAMIN K 0.2MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2024-11-06Labeling · Supplement 44 · standard — Label ↗AP
2016-03-17Labeling · Supplement 30 · standard — Label ↗AP
2015-12-02Manufacturing (CMC) · Supplement 31 · standardAP
2014-11-11Manufacturing (CMC) · Supplement 26 · standardAP
2014-09-04Manufacturing (CMC) · Supplement 25 · standardAP
2008-12-17Manufacturing (CMC) · Supplement 15 — Label ↗AP
2006-08-22Manufacturing (CMC) · Supplement 13AP
2003-02-12Labeling · Supplement 5 · standard — Letter ↗AP
2002-07-10Manufacturing (CMC) · Supplement 4 · standardAP
2002-07-09Manufacturing (CMC) · Supplement 3 · standardAP
2001-10-03Labeling · Supplement 1 · standard — Label ↗AP
2001-06-26Manufacturing (CMC) · Supplement 2 · standardAP
2001-02-21Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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