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General MedicationsORALStandard

DYANAVEL XR 20

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Standard Dose
16MG;EQ 4MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DYANAVEL XR 20 is listed in Drugs@FDA under application 210526 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview DYANAVEL XR 20 is listed in Drugs@FDA under application 210526 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-09-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.