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M.V.I.-12 (without Vitamin K) Drug - M.V.I.-12 (without Vitamin K) 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; Vitamin E Multiple ingredients are in alphabetical order. Strength - 20MG/ML;0.006MG/ML;0.05UGM/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/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; Vitamin E. May repeat for multiple part products. Applicant - MAYNE PHARMA USA The firm name holding legal responsibility for M.V.I.-12 (without Vitamin K). The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 008809 The FDA assigned number to M.V.I.-12 (without Vitamin K). Format is nnnnnn. Product Number - 006 The FDA assigned number to identify M.V.I.-12 (without Vitamin K). 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 - Sep 9, 2004 The date M.V.I.-12 (without Vitamin K) 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 M.V.I.-12 (without Vitamin K). 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 M.V.I.-12 (without Vitamin K) is in. Format is RX, OTC, DISCN. Applicant Full Name - Mayne Pharma Usa Inc The full name of the firm holding legal responsibility for the new application of M.V.I.-12 (without Vitamin K). M.V.I.-12 (without Vitamin K) Abilify 5mg Tablet; Oral Trisenox 1mg/ml Injectable; Injection Septocaine 4%;eq 0.01mg Base/ml Injectable; Injection 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 M.V.C. 9+3 10mg/ml;0.006mg/ml;0.5ugm/ml;1.5mg/ml;20 Iu/ml;0.04mg/ml;4mg/ml;0.4mg/ml;0.36mg/ml;0.3mg/ml;330 Units/ml;1 Iu/ml Injectable; Injection M.V.I.-12 10mg/ml;0.006mg/ml;0.5ugm/ml;1.5mg/ml;20 Iu/ml;0.04mg/ml;4mg/ml;0.4mg/ml;0.36mg/ml;0.3mg/ml;330 Units/ml;1 Iu/ml Injectable; Injection M.V.I.-12 (without Vitamin K) 20mg/ml;0.006mg/ml;0.05ugm/ml;1.5mg/ml;0.0005mg/ml;0.06mg/ml;4mg/ml;0.6mg/ml;0.36mg/ml;0.6mg/ml;0.1mg/ml;1mg/ml Injectable; Injection NewDrugInformation