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Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
McKinsey
Teva
Cantor Fitzgerald
UBS
US Army
Colorcon
Novartis
Queensland Health

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204602

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NDA 204602 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, Sun Pharm Inds Inc, Ucb Inc, and Vintage Pharms, and is included in forty 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 204602
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Novel Labs Inc
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204602
Suppliers and Packaging for NDA: 204602
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 204602 ANDA Novel laboratories, Inc. 40032-930 E 40032-930-05
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride SOLUTION;ORAL 204602 ANDA Novel laboratories, Inc. 40032-931 N 40032-931-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Aug 14, 2015TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Aug 14, 2015TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Johnson and Johnson
Julphar
McKinsey
QuintilesIMS
Moodys
Teva

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