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General MedicationsORALStandard

AZSTARYS

DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

Standard Dose
EQ 7.8MG BASE;EQ 39.2MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AZSTARYS is listed in Drugs@FDA under application 212994 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE Form and strength CAPSULE;ORAL - EQ 7.8MG BASE;EQ 39.2MG BASE Sponsor COMMAVE THERAP Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview AZSTARYS is listed in Drugs@FDA under application 212994 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE Form and strength CAPSULE;ORAL - EQ 7.8MG BASE;EQ 39.2MG BASE Sponsor COMMAVE THERAP 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.