Dexmethylphenidate Hydrochloride

ANDA 202580, held by Aurolife Pharma LLC. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 202580 (Dexmethylphenidate Hydrochloride), held by Aurolife Pharma LLC, was first approved by FDA on Aug 28, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2013
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Aug 28, 2013	Original application	Approved	Letter

Products

8 strengths and forms


Dexmethylphenidate Hydrochloride30MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride5MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride10MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride15MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride20MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride25MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride35MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride40MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Mar 19, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Mar 19, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Mar 19, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Nov 12, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jan 23, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Aug 28, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 202580
Drugs@FDA: Overview at FDA
Company: Aurolife Pharma

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