APPLICATION
NDA006071
TYPE
NDA
ORIGINAL APPROVAL
1947-07-28
LATEST ACTION
1996-04-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BEROCCA PNDiscontinued
ASCORBIC ACID 50MG/ML, BIOTIN 0.03MG/ML, CYANOCOBALAMIN 0.0025MG/ML, DEXPANTHENOL 7.5MG/ML, ERGOCALCIFEROL 100 IU/ML, FOLIC ACID 0.2MG/ML, NIACINAMIDE 20MG/ML, PYRIDOXINE HYDROCHLORIDE 2MG/ML, RIBOFLAVIN 5'-PHOSPHATE SODIUM 1.8MG/ML, THIAMINE HYDROCHLORIDE 1.5MG/ML, VITAMIN A PALMITATE 1,650 IU/ML, VITAMIN E 5 IU/ML · INJECTABLE · INJECTION
Approval history
1996-04-26Labeling · Supplement 9AP
1987-07-13Labeling · Supplement 16AP
1985-10-10Labeling · Supplement 11AP
1979-12-12Labeling · Supplement 7AP
1947-07-28UNKNOWN · Original · unknownAP
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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