Berocca Pn

   
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Berocca Pn


Drug - Berocca Pn
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin Phosphate Sodium; Thiamine Hydrochloride; Vitamin A Palmitate; Vitamin E
Multiple ingredients are in alphabetical order.

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
The potency of the active ingredient(s), Ascorbic Acid; Biotin; Cyanocobalamin; Dexpanthenol; Ergocalciferol; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin Phosphate Sodium; Thiamine Hydrochloride; Vitamin A Palmitate; Vitamin E. May repeat for multiple part products.

Applicant - ROCHE
The firm name holding legal responsibility for Berocca Pn. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 006071
The FDA assigned number to Berocca Pn. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Berocca Pn. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Oct 10, 1985
The date Berocca Pn was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD) - No
The pioneer or innovator of Berocca Pn. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Berocca Pn is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Berocca Pn.

Berocca Pn


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Infuvite Pediatric 80mg/vial;0.02mg/vial;400 Iu/vial;0.001mg/vial;5mg/vial;0.14mg/vial;17mg/vial;1mg/vial;1.4mg/vial;1.2mg/vial;7 Iu/vial;2,300 Iu/vial;0.2mg/vial Injectable; Iv (infusion)
Infuvite Pediatric (pharmacy Bulk Package) 80mg/vial;0.02mg/vial;400 Iu/vial;0.001mg/vial;5mg/vial;0.14mg/vial;17mg/vial;1mg/vial;1.4mg/vial;1.2mg/vial;7 Iu/vial;2,300 Iu/vial;0.2mg/vial Injectable; Iv (infusion)
M.V.I. Pediatric 80mg/vial;0.02mg/vial;0.001mg/vial;5mg/vial;0.01mg/vial;0.14mg/vial;17mg/vial;0.2mg/vial;1mg/vial;1.4mg/vial;eq 1.2mg Base/vial;0.7mg/vial;7mg/vial For Solution; Iv (infusion)
Berocca Pn 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 Injectable; Injection
Abilify 20mg Tablet; Oral
Abilify 2mg Tablet; Oral
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