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Adderall 10 Drug - Adderall 10 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) - Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Multiple ingredients are in alphabetical order. Strength - 2.5MG;2.5MG;2.5MG;2.5MG 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 10. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 011522 The FDA assigned number to Adderall 10. Format is nnnnnn. Product Number - 007 The FDA assigned number to identify Adderall 10. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AB The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Feb 13, 1996 The date Adderall 10 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 10. 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 10 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 10. Adderall 10 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 Adderall Xr 30 7.5mg;7.5mg;7.5mg;7.5mg Capsule, Extended Release; Oral Adderall Xr 5 1.25mg;1.25mg;1.25mg;1.25mg Capsule, Extended Release; Oral Adderall 10 2.5mg;2.5mg;2.5mg;2.5mg Tablet; Oral Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For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