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Adzenys ER Approval History

  • FDA approved: Yes (First approved September 15th, 2017)
  • Brand name: Adzenys ER
  • Generic name: amphetamine
  • Dosage form: Extended-Release Liquid Suspension
  • Previous name: NT-0201
  • Company: Neos Therapeutics, Inc.
  • Treatment for: ADHD

Adzenys ER (amphetamine) is an extended-release liquid suspension formulation of the central nervous system (CNS) stimulant amphetamine indicated for the treatment of ADHD in patients 6 years and older.

Development History and FDA Approval Process for Adzenys ER

Sep 15, 2017Approval Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD
Nov 17, 2016Neos Therapeutics Submits NDA for Amphetamine Extended-Release Liquid Suspension Drug Candidate, NT-0201, for the Treatment of ADHD

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