Infuvite Pediatric

   
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Infuvite Pediatric


Drug - Infuvite Pediatric
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; IV (INFUSION)
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ascorbic Acid; Biotin; Cholecalciferol; Cyanocobalamin; Dexpanthenol; Folic Acid; Niacinamide; Pyridoxine; Riboflavin; Thiamine; Tocopherol Acetate; Vitamin A; Vitamin K
Multiple ingredients are in alphabetical order.

Strength - 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
The potency of the active ingredient(s), Ascorbic Acid; Biotin; Cholecalciferol; Cyanocobalamin; Dexpanthenol; Folic Acid; Niacinamide; Pyridoxine; Riboflavin; Thiamine; Tocopherol Acetate; Vitamin A; Vitamin K. May repeat for multiple part products.

Applicant - SABEX 2002
The firm name holding legal responsibility for Infuvite Pediatric. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021265
The FDA assigned number to Infuvite Pediatric. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Infuvite Pediatric. 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 - Feb 21, 2001
The date Infuvite Pediatric 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) - Yes
The pioneer or innovator of Infuvite Pediatric. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Sabex 2002 Inc
The full name of the firm holding legal responsibility for the new application of Infuvite Pediatric.

Infuvite Pediatric