APPLICATION
NDA021643
TYPE
NDA
ORIGINAL APPROVAL
2004-02-18
LATEST ACTION
2017-11-09
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
M.V.I. ADULT (PHARMACY BULK PACKAGE) · ReferenceDiscontinued
ASCORBIC ACID 200MG/5ML, BIOTIN 0.06MG/5ML, CYANOCOBALAMIN 0.005MG/5ML, DEXPANTHENOL 15MG/5ML, ERGOCALCIFEROL 0.005MG/5ML, FOLIC ACID 0.6MG/5ML, NIACINAMIDE 40MG/5ML, PYRIDOXINE HYDROCHLORIDE 6MG/5ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 3.6MG/5ML, THIAMINE HYDROCHLORIDE 6MG/5ML, VITAMIN A 1MG/5ML, VITAMIN E 10MG/5ML, VITAMIN K 0.15MG/5ML · INJECTABLE · INTRAVENOUS
Approval history
2013-03-19Manufacturing (CMC) · Supplement 14 · standardAP
2009-11-24Manufacturing (CMC) · Supplement 8AP
2004-02-18Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Review ↗AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.