Jornay Pm

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 209311, held by Ironshore Pharms. Methylphenidate Hydrochloride.

As of Nov 14, 2026, NDA 209311 (Jornay Pm), held by Ironshore Pharms, was first approved by FDA on Aug 8, 2018, with 5 approved supplements and 1 published complete response letter.

First approved: Aug 8, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

JORNAY PM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use The use of Jornay PM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 8, 2018	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jul 28, 2017	Jornay PM (methylphenidate hydrochloride)Clinical	Approved

Products

5 strengths and forms


Jornay Pm20MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Jornay Pm40MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Jornay Pm60MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Jornay Pm80MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Jornay Pm100MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Aug 20, 2026	Supplement 15Manufacturing	Approved	Label Letter
Sep 23, 2025	Supplement 13Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 10Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 8Labeling	Approved	Label Letter
May 16, 2019	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 8, 2018	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 209311
Drugs@FDA: Overview at FDA
Company: Ironshore Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters