Aptensio Xr

Treats Attention Deficit Hyperactivity Disorder (ADHD ). NDA 205831, held by Rhodes Pharms. Methylphenidate Hydrochloride.

As of Nov 14, 2026, NDA 205831 (Aptensio Xr), held by Rhodes Pharms, was first approved by FDA on Apr 17, 2015, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2015
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD ) in patients 6 years and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Jun 14, 2019	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 17, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

7 strengths and forms


Aptensio Xr10MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr15MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr20MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr30MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr40MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr50MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Aptensio Xr60MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 12Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 8Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 6Labeling	Approved	Letter Label
Jun 14, 2019	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 4, 2017	Supplement 3Labeling	Approved	Letter Label
Sep 15, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 17, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205831
Drugs@FDA: Overview at FDA
Company: Rhodes 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