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methylphenidate hydrochloride

FDA Drug Profile — RELEXXII, METADATE CD, methylphenidate hydrochloride, APTENSIO XR, Ritalin LA

Drug Details

Generic Name: methylphenidate hydrochloride
Brand Names: RELEXXII, METADATE CD, methylphenidate hydrochloride, APTENSIO XR, Ritalin LA, Quillivant XR, methylphenidate hydrochloride CD, Methylphenidate Hydrochloride Extended-Release, Ritalin
Application Number: NDA216117
Sponsor: Societal CDMO Gainesville, LLC
NDC Codes: 50
Dosage Forms: CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, SUSPENSION, EXTENDED RELEASE, TABLET
Routes: ORAL
Active Ingredients: METHYLPHENIDATE 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 ).