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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Argus Health

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207901

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NDA 207901 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 207901
Pharmacology for NDA: 207901
Medical Subject Heading (MeSH) Categories for 207901
Suppliers and Packaging for NDA: 207901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 207901 ANDA Tris Pharma Inc 27808-091 N 27808-091-01
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 207901 ANDA Tris Pharma Inc 27808-092 N 27808-092-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 26, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 26, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
Express Scripts
US Army

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