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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cerilliant
Cantor Fitzgerald
Boehringer Ingelheim
Express Scripts
Moodys
Teva
Colorcon
US Department of Justice
McKesson

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204595

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NDA 204595 describes FELBAMATE, which is a drug marketed by Taro Pharm, Zydus Pharms Usa Inc, Amneal Pharms, Impax Labs Inc, and Alvogen Malta, and is included in seven NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the felbamate profile page.

Summary for NDA: 204595

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 204595

Suppliers and Packaging for NDA: 204595

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBAMATE
felbamate
TABLET;ORAL 204595 ANDA Mylan Pharmaceuticals Inc. 0378-4110 0378-4110-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-4110-01)
FELBAMATE
felbamate
TABLET;ORAL 204595 ANDA Mylan Pharmaceuticals Inc. 0378-4111 0378-4111-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-4111-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jan 11, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 11, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

McKinsey
McKesson
QuintilesIMS
Colorcon
US Army
UBS
Medtronic
Moodys
Cipla
Chinese Patent Office

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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