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Serving 500+ biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Boehringer Ingelheim
US Army
McKinsey
Harvard Business School
Colorcon
Argus Health
Chinese Patent Office
Novartis

Generated: June 22, 2017

DrugPatentWatch Database Preview

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-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 089601

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089601

Physiological EffectCentral Nervous System Stimulation

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 53014-594-07 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (53014-594-07)
METADATE ER
methylphenidate hydrochloride
 TABLET, EXTENDED RELEASE;ORAL 089601 ANDA Upstate Pharma, LLC 65580-594 65580-594-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65580-594-01)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Dow
AstraZeneca
Colorcon
Chinese Patent Office
Julphar
UBS
Chubb
Teva
Merck
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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