APPLICATION
NDA018440
TYPE
NDA
ORIGINAL APPROVAL
1981-11-06
LATEST ACTION
1996-04-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
M.V.C. 9+3Discontinued
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
1996-04-26Labeling · Supplement 24AP
1996-04-26Labeling · Supplement 12AP
1996-04-26Labeling · Supplement 15AP
1996-04-26Labeling · Supplement 6AP
1992-07-01Labeling · Supplement 30AP
1992-06-30Labeling · Supplement 27AP
1982-11-18Labeling · Supplement 4AP
1982-05-05Labeling · Supplement 2AP
1981-11-06Type 5 - New Formulation or New Manufacturer · 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.
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