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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207488

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NDA 207488 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 thirty 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-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 207488
Applicant:Abhai Llc
Ingredient:methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207488
Suppliers and Packaging for NDA: 207488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207488 ANDA KVK-Tech, Inc. 10702-075 N 10702-075-06
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207488 ANDA KVK-Tech, Inc. 10702-075 N 10702-075-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 9, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 9, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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