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General MedicationsORALGeneric

ADZENYS ER

AMPHETAMINE

Standard Dose
EQ 1.25MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview ADZENYS ER is listed in Drugs@FDA under application 204325 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient AMPHETAMINE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML Sponsor NEOS THERAPS INC Submission history Latest submission status date: 2022-02-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview ADZENYS ER is listed in Drugs@FDA under application 204325 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient AMPHETAMINE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML Sponsor NEOS THERAPS INC Submission history Latest submission status date: 2022-02-25 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.