General MedicationsORALStandard
JORNAY PM
METHYLPHENIDATE HYDROCHLORIDE
Standard Dose
100MG
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 - 100MG 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 - 100MG 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.