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Serving leading biopharmaceutical companies globally:

Dow
Covington
Daiichi Sankyo
McKinsey
Farmers Insurance
Medtronic
Fish and Richardson
Johnson and Johnson
Moodys
Accenture

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201680

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NDA 201680 describes FELBAMATE, which is a drug marketed by Amneal Pharms, Taro Pharm, Alvogen Malta, Impax Labs Inc, and Zydus Pharms Usa Inc, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the FELBAMATE profile page.

The generic ingredient in FELBAMATE is felbamate. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 201680
Tradename:FELBAMATE
Applicant:Amneal Pharms
Ingredient:felbamate
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 201680
Suppliers and Packaging for NDA: 201680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBAMATE felbamate TABLET;ORAL 201680 ANDA Marlex Pharmaceuticals Inc 10135-601 10135-601-90 90 TABLET in 1 BOTTLE (10135-601-90)
FELBAMATE felbamate TABLET;ORAL 201680 ANDA Marlex Pharmaceuticals Inc 10135-602 10135-602-90 90 TABLET in 1 BOTTLE (10135-602-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 13, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Sep 13, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cipla
AstraZeneca
McKesson
QuintilesIMS
Fish and Richardson
Healthtrust
Fuji
Citi

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