dexmethylphenidate hydrochloride

FDA Drug Profile — Dexmethylphenidate Hydrochloride, Focalin, Focalin XR, Dexmethylphenidate Hydrochloride Extended-Release, DEXMETHYLPHENIDATE HYDROCHLORIDE

Drug Details

Generic Name
dexmethylphenidate hydrochloride
Brand Names
Dexmethylphenidate Hydrochloride, Focalin, Focalin XR, Dexmethylphenidate Hydrochloride Extended-Release, DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
ANDA207901
Sponsor
Bryant Ranch Prepack
NDC Codes
50
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
DEXMETHYLPHENIDATE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).