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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Medtronic
Accenture
Healthtrust
Baxter
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Boehringer Ingelheim
Farmers Insurance
Covington

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090710

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NDA 090710 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Ascent Pharms Inc, Tedor Pharma Inc, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Cnty Line Pharms, Lannett Co Inc, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in forty-four NDAs. It is available from twenty-nine suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 090710
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Sun Pharm Inds Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090710
Suppliers and Packaging for NDA: 090710
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 090710 ANDA Sun Pharmaceutical Industries, Inc. 57664-228 N 57664-228-08
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 090710 ANDA Sun Pharmaceutical Industries, Inc. 57664-228 N 57664-228-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 15, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Mar 15, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Julphar
Merck
Baxter
Fish and Richardson
AstraZeneca
US Department of Justice
Deloitte

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