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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 204266


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NDA 204266 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 Inc, 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 fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 204266
Tradename:DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant:Aurolife Pharma Llc
Ingredient:dexmethylphenidate hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 204266
Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Aug 25, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Aug 25, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Aug 25, 2015TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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