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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Queensland Health

Generated: June 23, 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, Ani Pharms 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
Applicant:Amneal Pharms
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 N 10135-601-90
FELBAMATE felbamate TABLET;ORAL 201680 ANDA Marlex Pharmaceuticals Inc 10135-602 N 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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Express Scripts
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