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Serving leading biopharmaceutical companies globally:

UBS
US Army
McKesson
AstraZeneca
Johnson and Johnson
Colorcon
Novartis
Fuji
Express Scripts
QuintilesIMS

Generated: January 22, 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, Novel Labs Inc, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in fourteen 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. Eighteen 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 49884-428-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-01)
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992 ANDA Par Pharmaceuticals, Inc. 49884-428 49884-428-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (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 leading biopharmaceutical companies globally:

McKesson
Julphar
Express Scripts
Novartis
Teva
Johnson and Johnson
Healthtrust
Federal Trade Commission
Covington

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