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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 079108

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NDA 079108 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Adare Pharms Inc, Granules Pharms, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Alkem Labs Ltd, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, Tris Pharma Inc, and Uspharma, and is included in twenty 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 079108
Pharmacology for NDA: 079108
Medical Subject Heading (MeSH) Categories for 079108
Suppliers and Packaging for NDA: 079108
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079108 ANDA Amneal Pharmaceuticals of New York LLC 0115-1682 0115-1682-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1682-01)
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079108 ANDA Amneal Pharmaceuticals of New York LLC 0115-1683 0115-1683-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1683-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Aug 5, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Aug 5, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:May 19, 2014TE:ABRLD:No

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