APPLICATION
NDA018439
TYPE
NDA
ORIGINAL APPROVAL
1982-07-13
LATEST ACTION
1999-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MVC PLUSDiscontinued
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
1999-02-10Manufacturing (CMC) · Supplement 20 · standardAP
1998-07-16Manufacturing (CMC) · Supplement 19 · standardAP
1998-02-26Manufacturing (CMC) · Supplement 18 · standardAP
1997-09-26Manufacturing (CMC) · Supplement 17 · standardAP
1996-12-24Manufacturing (CMC) · Supplement 15 · standardAP
1996-12-10Manufacturing (CMC) · Supplement 16 · standardAP
1996-02-27Labeling · Supplement 14 · standardAP
1994-10-14Manufacturing (CMC) · Supplement 13 · standardAP
1993-11-01Manufacturing (CMC) · Supplement 12 · standardAP
1989-12-05Manufacturing (CMC) · Supplement 10 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 8 · standardAP
1985-05-14Manufacturing (CMC) · Supplement 2 · standardAP
1983-01-17Manufacturing (CMC) · Supplement 1 · 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.
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