Viewing data from:

M.V.I. PEDIATRIC

NDA

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | N018920 | HOSPIRA INC

1 strength0 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Apotex Inc FDA-2026-P-2305 Apotex Inc. submitted this petition requesting that the FDA determine whether two multiple vitamins for injection products held by Hospira Inc.—M.V.I. Pediatric (NDA 018920) and M.V.I. Adult (NDA 021625)—were withdrawn from sale for reasons of safety or efficacy, as required under 21 CFR 314.161 bef	505(q)	2026-03-05	Open	Apotex Inc

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2019	SUPPL -38	View Letter (PDF)
Nov 13, 2017	SUPPL -36	View Letter (PDF)
Jul 8, 2002	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

RLD

0 patents0 exclusivities▴

FOR SOLUTION;INTRAVENOUS | Approved: Sep 21, 2000

No patent or exclusivity listings for this strength.