APPLICATION
NDA018920
TYPE
NDA
ORIGINAL APPROVAL
1983-04-06
LATEST ACTION
2019-02-14
ROUTE
INTRAVENOUS
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
M.V.I. PEDIATRIC · ReferenceDiscontinued
ASCORBIC ACID 80MG/VIAL, BIOTIN 0.02MG/VIAL, CYANOCOBALAMIN 0.001MG/VIAL, DEXPANTHENOL 5MG/VIAL, ERGOCALCIFEROL 0.01MG/VIAL, FOLIC ACID 0.14MG/VIAL, NIACINAMIDE 17MG/VIAL, PHYTONADIONE 0.2MG/VIAL, PYRIDOXINE HYDROCHLORIDE 1MG/VIAL, RIBOFLAVIN 5'-PHOSPHATE SODIUM 1.4MG/VIAL, THIAMINE HYDROCHLORIDE EQ 1.2MG BASE/VIAL, VITAMIN A 0.7MG/VIAL, VITAMIN E 7MG/VIAL · FOR SOLUTION · INTRAVENOUS
Approval history
2013-06-27Manufacturing (CMC) · Supplement 34 · priorityAP
2001-11-30Manufacturing (CMC) · Supplement 25 · priorityAP
2001-06-05Manufacturing (CMC) · Supplement 19 · priorityAP
2001-06-05Manufacturing (CMC) · Supplement 23 · priorityAP
2000-11-02Manufacturing (CMC) · Supplement 22 · priorityAP
2000-09-21Labeling · Supplement 20 · standardAP
2000-09-21Manufacturing (CMC) · Supplement 21 · priorityAP
2000-04-12Manufacturing (CMC) · Supplement 18 · priorityAP
1999-08-13Manufacturing (CMC) · Supplement 17 · priorityAP
1998-12-16Manufacturing (CMC) · Supplement 16 · priorityAP
1998-03-25Labeling · Supplement 15 · standardAP
1996-04-09Labeling · Supplement 14 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 13 · priorityAP
1995-10-18Manufacturing (CMC) · Supplement 11 · priorityAP
1995-05-26Manufacturing (CMC) · Supplement 10 · priorityAP
1993-02-24Manufacturing (CMC) · Supplement 9 · priorityAP
1993-02-22Labeling · Supplement 8AP
1991-04-19Labeling · Supplement 7AP
1989-06-22Labeling · Supplement 6AP
1986-12-08Manufacturing (CMC) · Supplement 5 · priorityAP
1986-12-03Labeling · Supplement 4AP
1985-05-15Labeling · Supplement 3AP
1984-07-06Labeling · Supplement 1AP
1984-07-06Labeling · Supplement 2AP
1983-04-06Type 4 - New Combination · Original · priorityAP
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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