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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKesson
AstraZeneca
US Army
McKinsey
Merck
Argus Health
Chubb
Covington

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203583

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NDA 203583 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, Cnty Line Pharms, Lannett Co Inc, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, 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 203583
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203583
Suppliers and Packaging for NDA: 203583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583 ANDA SpecGx LLC 0406-1810 N 0406-1810-01
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583 ANDA SpecGx LLC 0406-1820 N 0406-1820-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Sep 29, 2015TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Sep 29, 2015TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 29, 2015TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Fish and Richardson
Cerilliant
Harvard Business School
Farmers Insurance
Julphar
Teva
Express Scripts

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