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Focalin XR Approval History

  • FDA approved: Yes (First approved May 26th, 2005)
  • Brand name: Focalin XR
  • Generic name: dexmethylphenidate
  • Dosage form: Extended-Release Capsules
  • Company: Novartis Pharmaceuticals Corporation
  • Treatment for: ADHD

Focalin XR (dexmethylphenidate) is a once-daily extended-release form of Focalin indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

Development History and FDA Approval Process for Focalin XR

Nov 12, 2008Approval FDA Approves 30-Minute Onset of Action for Focalin XR
May 26, 2005Approval Focalin XR Novartis Pharmaceuticals Corporation - Treatment for Attention-Deficit/Hyperactivity Disorder (ADHD)

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