Skip to Content

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

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide