APPLICATION
NDA008809
TYPE
NDA
ORIGINAL APPROVAL
1953-02-20
LATEST ACTION
2017-11-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
M.V.I.-12 ADULTDiscontinued
ASCORBIC ACID 20MG/ML, BIOTIN 0.006MG/ML, CYANOCOBALAMIN 0.5MCG/ML, DEXPANTHENOL 1.5MG/ML, ERGOCALCIFEROL 20 IU/ML, FOLIC ACID 0.6MG/ML, NIACINAMIDE 4MG/ML, PYRIDOXINE HYDROCHLORIDE 0.4MG/ML, RIBOFLAVIN 0.36MG/ML, THIAMINE HYDROCHLORIDE 0.6MG/ML, VITAMIN A 330 UNITS/ML, VITAMIN E 1 IU/ML · INJECTABLE · INJECTION
M.V.I.-12 ADULT · ReferenceDiscontinued
ASCORBIC ACID 20MG/ML, BIOTIN 0.006MG/ML, CYANOCOBALAMIN 0.05MCG/ML, DEXPANTHENOL 1.5MG/ML, ERGOCALCIFEROL 0.0005MG/ML, FOLIC ACID 0.06MG/ML, NIACINAMIDE 4MG/ML, PYRIDOXINE HYDROCHLORIDE 0.6MG/ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 0.36MG/ML, THIAMINE HYDROCHLORIDE 0.6MG/ML, VITAMIN A 0.1MG/ML, VITAMIN E 1MG/ML · INJECTABLE · INJECTION
M.V.I.-12 ADULTDiscontinued
ASCORBIC ACID 10MG/ML, BIOTIN 0.006MG/ML, CYANOCOBALAMIN 0.5MCG/ML, DEXPANTHENOL 1.5MG/ML, ERGOCALCIFEROL 20 IU/ML, FOLIC ACID 0.04MG/ML, NIACINAMIDE 4MG/ML, PYRIDOXINE HYDROCHLORIDE 0.4MG/ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 0.36MG/ML, THIAMINE HYDROCHLORIDE 0.3MG/ML, VITAMIN A 330 UNITS/ML, VITAMIN E 1 IU/ML · INJECTABLE · INJECTION
Approval history
2015-09-18Manufacturing (CMC) · Supplement 72 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 67 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 69 · standardAP
2009-11-24Manufacturing (CMC) · Supplement 60AP
2002-11-14Manufacturing (CMC) · Supplement 48 · standardAP
2002-06-04Manufacturing (CMC) · Supplement 47 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 44 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 45 · standardAP
2001-04-10Manufacturing (CMC) · Supplement 43 · standardAP
1999-08-02Manufacturing (CMC) · Supplement 42 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 41 · standardAP
1998-11-18Manufacturing (CMC) · Supplement 40 · standardAP
1998-05-12Manufacturing (CMC) · Supplement 39 · standardAP
1998-03-30Manufacturing (CMC) · Supplement 37 · standardAP
1997-12-31Manufacturing (CMC) · Supplement 38 · standardAP
1997-09-22Manufacturing (CMC) · Supplement 36 · standardAP
1997-02-13Manufacturing (CMC) · Supplement 35 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 33 · standardAP
1995-10-27Manufacturing (CMC) · Supplement 31 · standardAP
1995-05-26Manufacturing (CMC) · Supplement 30 · standardAP
1993-02-24Manufacturing (CMC) · Supplement 29 · standardAP
1993-02-03Manufacturing (CMC) · Supplement 28 · standardAP
1993-02-02Manufacturing (CMC) · Supplement 27 · standardAP
1991-04-19Labeling · Supplement 25AP
1990-12-07Manufacturing (CMC) · Supplement 24 · standardAP
1989-06-22Labeling · Supplement 23AP
1985-08-08Labeling · Supplement 21AP
1985-04-25Manufacturing (CMC) · Supplement 19 · standardAP
1985-04-24Manufacturing (CMC) · Supplement 20 · standardAP
1984-09-20Labeling · Supplement 18AP
1980-06-23Labeling · Supplement 5AP
1953-02-20Type 4 - New Combination · Original · standardAP
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.