Dexmethylphenidate Hydrochloride

ANDA 77107, held by Teva Pharms. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 77107 (Dexmethylphenidate Hydrochloride), held by Teva Pharms, was first approved by FDA on Jan 29, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2007
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 29, 2007	Original application	Approved	Letter

Products

3 strengths and forms


Dexmethylphenidate Hydrochloride5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride10MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride2.5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Sep 28, 2026	Supplement 17Labeling · Standard review	Approved	None posted
Sep 28, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Sep 28, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Mar 13, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Mar 13, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 29, 2011	Supplement 6Labeling	Approved	None posted
Jul 16, 2008	Supplement 3Labeling	Approved	None posted
Aug 29, 2007	Supplement 2Labeling	Approved	None posted
Aug 29, 2007	Supplement 1Labeling	Approved	None posted
Jan 29, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 77107
Drugs@FDA: Overview at FDA
Company: Teva 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