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Adderall Xr 25 Drug - Adderall Xr 25 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 Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Multiple ingredients are in alphabetical order. Strength - 6.25MG;6.25MG;6.25MG;6.25MG The potency of the active ingredient(s), Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate. May repeat for multiple part products. Applicant - SHIRE The firm name holding legal responsibility for Adderall Xr 25. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 021303 The FDA assigned number to Adderall Xr 25. Format is nnnnnn. Product Number - 004 The FDA assigned number to identify Adderall Xr 25. 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 - May 22, 2002 The date Adderall Xr 25 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 Adderall Xr 25. 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 Adderall Xr 25 is in. Format is RX, OTC, DISCN. Applicant Full Name - Shire Development Inc The full name of the firm holding legal responsibility for the new application of Adderall Xr 25. Adderall Xr 25 Adderall Xr 20 5mg;5mg;5mg;5mg Capsule, Extended Release; Oral Adderall Xr 25 6.25mg;6.25mg;6.25mg;6.25mg Capsule, Extended Release; Oral Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Adderall Xr 10 2.5mg;2.5mg;2.5mg;2.5mg Capsule, Extended Release; Oral Adderall Xr 15 3.75mg;3.75mg;3.75mg;3.75mg Capsule, Extended Release; Oral NewDrugInformation