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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Merck
UBS
Covington
QuintilesIMS
Johnson and Johnson
Harvard Business School
McKesson
Julphar
US Army

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204115

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NDA 204115 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Ascent Pharms Inc, Tedor Pharma Inc, Able, Actavis Elizabeth, Amneal Pharms, Cnty Line Pharms, Kremers Urban Pharms, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Sun Pharm Inds Inc, Ucb Inc, and Vintage Pharms, and is included in forty NDAs. It is available from twenty-eight 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 204115
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Novel Labs Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204115
Suppliers and Packaging for NDA: 204115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204115 ANDA Novel Laboratories, Inc. 40032-570 N 40032-570-01
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204115 ANDA Novel Laboratories, Inc. 40032-571 N 40032-571-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength2.5MG
Approval Date:Feb 25, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 25, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Feb 25, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Baxter
Harvard Business School
Fish and Richardson
US Department of Justice
Julphar
Medtronic
Chubb
Accenture

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