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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 202580

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NDA 202580 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Adare Pharms Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Granules, Impax Labs Inc, Medicap Labs, Ph Health, Sun Pharm Inds Inc, Teva Pharms Usa, Abhai Llc, Alkem Labs Ltd, Bionpharma, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in twenty-two NDAs. It is available from fourteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for 202580

Tradename:	DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant:	Aurolife Pharma Llc
Ingredient:	dexmethylphenidate hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 202580

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Aug 28, 2013	TE:		RLD:	No

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