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Dyanavel XR FDA Approval History

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

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

Development timeline for Dyanavel XR

Nov  5, 2021Approval Tris Pharma Announces FDA Approval of Dyanavel XR (amphetamine) Once-Daily Extended-Release Oral Tablets, CII, for ADHD
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

Further information

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