NDA 006071

ROCHE

FDA Drug Application

Application #006071

Application Sponsors

NDA 006071

ROCHE

Marketing Status

• Discontinued: 003

Application Products

003

INJECTABLE;INJECTION

50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML

0

BEROCCA PN

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E

FDA Submissions

UNKNOWN;	ORIG	1	AP	1947-07-28	UNKNOWN
LABELING; Labeling	SUPPL	7	AP	1979-12-12
LABELING; Labeling	SUPPL	9	AP	1996-04-26
LABELING; Labeling	SUPPL	11	AP	1985-10-10
LABELING; Labeling	SUPPL	16	AP	1987-07-13

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6071
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEROCCA PN","activeIngredients":"ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E","strength":"50MG\/ML;0.03MG\/ML;0.0025MG\/ML;7.5MG\/ML;100 IU\/ML;0.2MG\/ML;20MG\/ML;2MG\/ML;1.8MG\/ML;1.5MG\/ML;1,650 IU\/ML;5 IU\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BEROCCA PN","submission":"ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E","actionType":"50MG\/ML;0.03MG\/ML;0.0025MG\/ML;7.5MG\/ML;100 IU\/ML;0.2MG\/ML;20MG\/ML;2MG\/ML;1.8MG\/ML;1.5MG\/ML;1,650 IU\/ML;5 IU\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)