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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Harvard Business School
Chinese Patent Office

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202385

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NDA 202385 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 202385
Applicant:Amneal Pharms
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 202385
Suppliers and Packaging for NDA: 202385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBAMATE felbamate SUSPENSION;ORAL 202385 ANDA Amneal Pharmaceuticals LLC 65162-686 65162-686-88 237 mL in 1 BOTTLE (65162-686-88)
FELBAMATE felbamate SUSPENSION;ORAL 202385 ANDA Amneal Pharmaceuticals LLC 65162-686 65162-686-90 473 mL in 1 BOTTLE (65162-686-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength600MG/5ML
Approval Date:Dec 16, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo

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