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Johnson and Johnson
Chinese Patent Office
US Army

Generated: February 25, 2018

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Details for New Drug Application (NDA): 089601

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NDA 089601 describes METADATE ER, which is a drug marketed by Ucb Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the METADATE ER profile page.

The generic ingredient in METADATE ER is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 089601
Applicant:Ucb Inc
Ingredient:methylphenidate hydrochloride
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089601
Suppliers and Packaging for NDA: 089601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METADATE ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Unither Manufacturing, LLC 53014-594 E 53014-594-07
METADATE ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Upstate Pharma, LLC 65580-594 N 65580-594-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 1, 1988TE:ABRLD:No

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Argus Health

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