General MedicationsORALStandard

AZSTARYS

DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE

Standard Dose

EQ 5.2MG BASE;EQ 26.1MG 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 5.2MG BASE;EQ 26.1MG 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 5.2MG BASE;EQ 26.1MG 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.