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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
US Department of Justice
McKesson
US Army
Fuji
Deloitte
Mallinckrodt
Dow
Chinese Patent Office

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200886

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NDA 200886 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, Actavis Labs Fl, Amneal Pharms, Cnty Line Pharms, Kremers Urban Pharms, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Bionpharma Inc, Lannett Co Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in forty-three 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 200886
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Mayne Pharma
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200886
Suppliers and Packaging for NDA: 200886
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 200886 ANDA Mayne Pharma 51862-262 N 51862-262-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 26, 2018TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Fuji
Baxter
Julphar
Teva
McKesson
US Department of Justice
Dow

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