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Biphetamine 12.5 Drug - Biphetamine 12.5 The trade name of the product as shown on the labeling. Dosage - CAPSULE, EXTENDED RELEASE; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Amphetamine Resin Complex; Dextroamphetamine Resin Complex Multiple ingredients are in alphabetical order. Strength - EQ 6.25MG BASE;EQ 6.25MG BASE The potency of the active ingredient(s), Amphetamine Resin Complex; Dextroamphetamine Resin Complex. May repeat for multiple part products. Applicant - UCB The firm name holding legal responsibility for Biphetamine 12.5. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 010093 The FDA assigned number to Biphetamine 12.5. Format is nnnnnn. Product Number - 007 The FDA assigned number to identify Biphetamine 12.5. 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 - Approved Prior to Jan 1, 1982 The date Biphetamine 12.5 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 Biphetamine 12.5. 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 Biphetamine 12.5 is in. Format is RX, OTC, DISCN. Applicant Full Name - Ucb Pharma Inc The full name of the firm holding legal responsibility for the new application of Biphetamine 12.5. Biphetamine 12.5 Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 1.25mg;1.25mg;1.25mg;1.25mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 2.5mg;2.5mg;2.5mg;2.5mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 5mg;5mg;5mg;5mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 7.5mg;7.5mg;7.5mg;7.5mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 1.25mg;1.25mg;1.25mg;1.25mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 2.5mg;2.5mg;2.5mg;2.5mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 5mg;5mg;5mg;5mg Tablet; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 7.5mg;7.5mg;7.5mg;7.5mg Tablet; Oral Biphetamine 12.5 Eq 6.25mg Base;eq 6.25mg Base Capsule, Extended Release; Oral Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate And Amp Sulfate 7.5mg;7.5mg;7.5mg;7.5mg Tablet; Oral NewDrugInformation