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General MedicationsORALStandard

JORNAY PM

METHYLPHENIDATE HYDROCHLORIDE

Standard Dose
80MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview JORNAY PM is listed in Drugs@FDA under application 209311 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 80MG Sponsor IRONSHORE PHARMS Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview JORNAY PM is listed in Drugs@FDA under application 209311 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 80MG Sponsor IRONSHORE PHARMS 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.