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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 006071

BEROCCA PN (ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E)
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
Marketing Status: Discontinued
Active Ingredient: ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E
Proprietary Name: BEROCCA PN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
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
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N006071
Product Number: 003
Approval Date: Oct 10, 1985
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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