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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
Chubb
Queensland Health
US Army
Daiichi Sankyo
Baxter
Cantor Fitzgerald
Julphar

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202731

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NDA 202731 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 202731
Pharmacology for NDA: 202731
Medical Subject Heading (MeSH) Categories for 202731
Suppliers and Packaging for NDA: 202731
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731 ANDA Teva Pharmaceuticals USA, Inc. 0093-5045 N 0093-5045-01
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731 ANDA Teva Pharmaceuticals USA, Inc. 0093-5046 N 0093-5046-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength25MG
Approval Date:Jul 5, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Nov 19, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:May 19, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Citi
Fuji
Dow
Healthtrust
Medtronic
Argus Health
Colorcon
UBS

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