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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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Dow
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Fish and Richardson
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091601

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NDA 091601 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-four 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-three suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 091601
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Tris Pharma Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091601
Suppliers and Packaging for NDA: 091601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 091601 ANDA Tris Pharma Inc 27808-058 N 27808-058-01
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 091601 ANDA Tris Pharma Inc 27808-059 N 27808-059-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Jul 23, 2010TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Jul 23, 2010TE:AARLD:No

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