Infuvite Pediatric, Infuvite Pediatric (Pharmacy Bulk Package)

Prevents vitamin deficiency. NDA 21265, held by Sandoz Canada Inc. Ascorbic Acid; Biotin; Cholecalciferol; Cyanocobalamin; Dexpanthenol; Folic Acid; Niacinamide; Pyridoxine; Riboflavin; Thiamine; Tocopherol Acetate; Vitamin A; Vitamin K.

As of Nov 14, 2026, NDA 21265 (Infuvite Pediatric, Infuvite Pediatric (Pharmacy Bulk Package)), held by Sandoz Canada Inc, was first approved by FDA on Feb 21, 2001, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 21, 2001
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 21, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label

Products

2 strengths and forms


Infuvite Pediatric80MG/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 · injectable;intravenous	Ascorbic Acid; Biotin; Cholecalciferol; Cyanocobalamin; Dexpanthenol; Folic Acid; Niacinamide; Pyridoxine; Riboflavin; Thiamine; Tocopherol Acetate; Vitamin A; Vitamin K	RxReference drug
Infuvite Pediatric (Pharmacy Bulk Package)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 · injectable;intravenous	Ascorbic Acid; Biotin; Cholecalciferol; Cyanocobalamin; Dexpanthenol; Folic Acid; Niacinamide; Pyridoxine; Riboflavin; Thiamine; Tocopherol Acetate; Vitamin A; Vitamin K	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Nov 6, 2024	Supplement 44Labeling · Standard review	Approved	Label Letter
Mar 17, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 2, 2015	Supplement 31Manufacturing · Standard review	Approved	None posted
Nov 11, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 4, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 17, 2008	Supplement 15Manufacturing	Approved	Label Letter
Aug 22, 2006	Supplement 13Manufacturing	Approved	None posted
Feb 12, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Jul 10, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 9, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 3, 2001	Supplement 1Labeling · Standard review	Approved	Label
Jun 26, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 21, 2001	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21265
Drugs@FDA: Overview at FDA
Company: Sandoz Canada

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters