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Adzenys ER FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved September 15, 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 timeline 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

Further information

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