BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
US Army

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040410

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NDA 040410 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, Bionpharma Inc, Sun Pharm Inds Inc, Ucb Inc, and Vintage Pharms, and is included in forty-two 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 040410
Applicant:Watson Labs
Ingredient:methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Feb 9, 2001TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Boehringer Ingelheim
Johnson and Johnson

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