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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fish and Richardson
Farmers Insurance
Johnson and Johnson
Covington
Moodys
Cerilliant
Queensland Health
Dow

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085799

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NDA 085799 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, Ani Pharms Inc, Cnty Line Pharms, Lannett Co Inc, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, Mountain, 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 085799
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 085799
Suppliers and Packaging for NDA: 085799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 085799 ANDA Lannett Company, Inc. 0527-2530 N 0527-2530-01
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 085799 ANDA Unither Manufacturing, LLC 53014-530 E 53014-530-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Teva
Cipla
Deloitte
Medtronic
Mallinckrodt
McKinsey
Julphar
Healthtrust

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