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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Covington
Chinese Patent Office
Queensland Health
QuintilesIMS
McKinsey
Farmers Insurance
Daiichi Sankyo
Julphar

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078992

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NDA 078992 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 thirteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 078992
Pharmacology for NDA: 078992
Medical Subject Heading (MeSH) Categories for 078992
Suppliers and Packaging for NDA: 078992
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992 ANDA Par Pharmaceuticals, Inc. 49884-428 N 49884-428-01
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992 ANDA Par Pharmaceuticals, Inc. 49884-428 N 49884-428-10

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Nov 18, 2013TE:ABRLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Nov 18, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Express Scripts
AstraZeneca
Citi
Dow
Teva
US Army
Federal Trade Commission
Fuji

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