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Dyanavel XR Approval History

  • FDA approved: Yes (First approved October 19th, 2015)
  • Brand name: Dyanavel XR
  • Generic name: amphetamine
  • Dosage form: Extended-Release Oral Suspension
  • Company: Tris Pharma, Inc.
  • Treatment for: ADHD

Dyanavel XR (amphetamine) is an extended-release central nervous system (CNS) stimulant in an oral suspension formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Development History and FDA Approval Process for Dyanavel XR

DateArticle
Oct 20, 2015Approval Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children
May 21, 2015Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel XR

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