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