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Axotal Drug - Axotal The trade name of the product as shown on the labeling. Dosage - TABLET; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Aspirin; Butalbital Multiple ingredients are in alphabetical order. Strength - 650MG;50MG The potency of the active ingredient(s), Aspirin; Butalbital. May repeat for multiple part products. Applicant - SAVAGE LABS The firm name holding legal responsibility for Axotal. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 088305 The FDA assigned number to Axotal. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Axotal. 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 13, 1983 The date Axotal 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 Axotal. 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 Axotal is in. Format is RX, OTC, DISCN. Applicant Full Name - Savage Laboratories Inc Div Altana Inc The full name of the firm holding legal responsibility for the new application of Axotal. Axotal Mvc Plus 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. Adult 200mg/vial;0.06mg/vial;0.005mg/vial;15mg/vial;0.005mg/vial;0.6mg/vial;40mg/vial;6mg/vial;3.6mg/vial;6mg/vial;1mg/vial;10mg/vial;0.15mg/vial Injectable; Iv (infusion) M.V.I. Adult (pharmacy Bulk Package) 200mg/5ml;0.06mg/5ml;0.005mg/5ml;15mg/5ml;0.005mg/5ml;0.6mg/5ml;40mg/5ml;6mg/5ml;3.6mg/5ml;6mg/5ml;1mg/5ml;10mg/5ml;0.15mg/5ml Injectable; Iv (infusion) M.V.I.-12 20mg/ml;0.006mg/ml;0.5ugm/ml;1.5mg/ml;20 Iu/ml;0.6mg/ml;4mg/ml;0.4mg/ml;0.36mg/ml;0.6mg/ml;330 Units/ml;1 Iu/ml Injectable; Injection M.V.I.-12 Lyophilized 100mg/vial;0.06mg/vial;0.005mg/vial;15mg/vial;5ugm/vial;0.4mg/vial;40mg/vial;4mg/vial;3.6mg/vial;3mg/vial;1mg/vial;10mg/vial Injectable; Injection Vitaped N/a,80mg/vial;n/a,0.02mg/vial;n/a,0.001mg/vial;400 Iu/10ml,n/a;n/a,0.14mg/vial;n/a,17mg/vial;n/a,5mg/vial;0.2mg/10ml,n/a;n/a,1mg/vial;n/a,1.4mg/vial;n/a,1.2mg/vial;eq 2,300 Units Base/10ml,n/a;7 Iu/10ml,n/a Injectable; Injection 8-hour Bayer 650mg Tablet, Extended Release; Oral Measurin 650mg Tablet, Extended Release; Oral Bayer Extra Strength Aspirin For Migraine Pain 500mg Tablet; Oral Axotal 650mg;50mg Tablet; Oral NewDrugInformation