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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202580

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NDA 202580 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in fifteen 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 five 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 202580
Pharmacology for NDA: 202580
Medical Subject Heading (MeSH) Categories for 202580
Suppliers and Packaging for NDA: 202580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202580 ANDA Mylan Pharmaceuticals Inc. 0378-4084 N 0378-4084-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Aug 28, 2013TE:ABRLD:No

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