Application Information

This drug has been submitted to the FDA under the reference 083563/001.

Names and composition

"DELCOBESE" is the commercial name of a drug composed of AMPHETAMINE ADIPATE and AMPHETAMINE SULFATE and DEXTROAMPHETAMINE ADIPATE and DEXTROAMPHETAMINE SULFATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
083563/001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 5MG and 5MG and 5MG and 5MG
083563/002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 3.75MG and 3.75MG and 3.75MG and 3.75MG
083563/003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 2.5MG and 2.5MG and 2.5MG and 2.5MG
083563/004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 1.25MG and 1.25MG and 1.25MG and 1.25MG
083564/001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 1.25MG and 1.25MG and 1.25MG and 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 2.5MG and 2.5MG and 2.5MG and 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 3.75MG and 3.75MG and 3.75MG and 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 5MG and 5MG and 5MG and 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
083563/001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 5MG and 5MG and 5MG and 5MG
083563/002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 3.75MG and 3.75MG and 3.75MG and 3.75MG
083563/003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 2.5MG and 2.5MG and 2.5MG and 2.5MG
083563/004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE TABLET/ORAL 1.25MG and 1.25MG and 1.25MG and 1.25MG
083564/001 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 1.25MG and 1.25MG and 1.25MG and 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/002 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 2.5MG and 2.5MG and 2.5MG and 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/003 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 3.75MG and 3.75MG and 3.75MG and 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
083564/004 DELCOBESE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE CAPSULE/ORAL 5MG and 5MG and 5MG and 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

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