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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209311
Company: IRONSHORE PHARMS

Medication Guide

Products on NDA 209311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JORNAY PM	METHYLPHENIDATE HYDROCHLORIDE	100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209311

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209311Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209311Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209311s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209311Orig1s013ltr.pdf
10/13/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209311s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209311Orig1s010ltr.pdf
06/25/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209311s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209311Orig1s008ltr.pdf
05/16/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209311Orig1s003ltr.pdf

Labels for NDA 209311

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209311s013lbl.pdf
10/13/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209311s010lbl.pdf
10/13/2023	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209311s010lbl.pdf
06/25/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209311s008lbl.pdf
05/16/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf
08/08/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf

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