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INFUVITE ADULT

NDA

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 | N021163 | SANDOZ CANADA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Strides Arcolab Limited - Citizen Petition FDA-2009-P-0417 · 3 docket documents Strides Arcolab Limited filed this citizen petition on March 25, 2009, resubmitted on August 24, 2009, requesting that the FDA declare MuVi 13 Adult-Multivitamin Injection and MuVi 13 Adult-Multivitamin Injection (Pharmacy Bulk Package) suitable for consideration in an abbreviated new drug applicati	Other	2009-09-04	WithdrawnUnverified summary	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$598.65

Highest Price

$648.24

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54643-5649-01INFUVITE ADULT INJ VIAL1+VIAL2=1 DOSE	$598.65	FSS	Baxter Healthcare Corporation	08/14/2026
54643-5650-02INFUVITE ADULT INJ VIAL1+VIAL2=1 DOSE	$648.24	FSS	Baxter Healthcare Corporation	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 7, 2024	SUPPL -45	View Letter (PDF)
Dec 11, 2008	SUPPL -16	View Letter (PDF)
Sep 17, 2004	SUPPL -11	View Letter (PDF)
Jun 7, 2004	SUPPL -5	View Letter (PDF)
May 18, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 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

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 18, 2000

No patent or exclusivity listings for this strength.

#002 — 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

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 16, 2003