← FDA DRUG APPROVALS

FDA NDA · NDA021625

M.V.I. ADULT

Sponsor: HOSPIRA

APPLICATION
NDA021625
TYPE
NDA
ORIGINAL APPROVAL
2004-01-30
LATEST ACTION
2020-12-16
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

M.V.I. ADULT · ReferenceDiscontinued
ASCORBIC ACID 200MG/VIAL, BIOTIN 0.06MG/VIAL, CYANOCOBALAMIN 0.005MG/VIAL, DEXPANTHENOL 15MG/VIAL, ERGOCALCIFEROL 0.005MG/VIAL, FOLIC ACID 0.6MG/VIAL, NIACINAMIDE 40MG/VIAL, PYRIDOXINE HYDROCHLORIDE 6MG/VIAL, RIBOFLAVIN 5'-PHOSPHATE SODIUM 3.6MG/VIAL, THIAMINE HYDROCHLORIDE 6MG/VIAL, VITAMIN A 1MG/VIAL, VITAMIN E 10MG/VIAL, VITAMIN K 0.15MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2020-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 23 · standard — Letter ↗AP
2015-06-24Manufacturing (CMC) · Supplement 20 · standardAP
2015-06-11Manufacturing (CMC) · Supplement 19 · standardAP
2015-01-21Labeling · Supplement 18 · standard — Letter ↗AP
2014-07-01Manufacturing (CMC) · Supplement 17 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 16 · standardAP
2009-11-24Manufacturing (CMC) · Supplement 9AP
2004-01-30Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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