← FDA DRUG APPROVALS

FDA NDA · NDA209311

JORNAY PM EXTENDED-RELEASE

methylphenidate hydrochloride

Sponsor: IRONSHORE PHARMS

APPLICATION
NDA209311
TYPE
NDA
ORIGINAL APPROVAL
2018-08-08
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

JORNAY PM · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 80MG · CAPSULE, EXTENDED RELEASE · ORAL
JORNAY PM · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
JORNAY PM · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
JORNAY PM · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
JORNAY PM · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 13 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 10 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 8 · 901 required — Label ↗AP
2019-05-16Labeling · Supplement 3 · standard — Letter ↗AP
2018-08-08Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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