General MedicationsORALStandard

DEXMETHYLPHENIDATE HYDROCHLORIDE

Standard Dose

5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DEXMETHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 215523 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMETHYLPHENIDATE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 5MG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-01-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXMETHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 215523 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMETHYLPHENIDATE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 5MG Sponsor ASCENT PHARMS INC Submission history Latest submission status date: 2025-01-15 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.