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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
US Army
Farmers Insurance
Daiichi Sankyo

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204595

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NDA 204595 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 204595
Applicant:Alvogen Malta
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 E 0378-4110-01
FELBAMATE felbamate TABLET;ORAL 204595 ANDA Mylan Pharmaceuticals Inc. 0378-4111 E 0378-4111-01

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Harvard Business School

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