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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 207093


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NDA 207093 describes FELBAMATE, which is a drug marketed by Amneal Pharms, Novitium Pharma, Taro, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in eight NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.
Summary for 207093
Tradename:FELBAMATE
Applicant:Taro
Ingredient:felbamate
Patents:0
Pharmacology for NDA: 207093
Suppliers and Packaging for NDA: 207093
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FELBAMATE felbamate TABLET;ORAL 207093 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-4185 51672-4185-1 100 TABLET in 1 BOTTLE (51672-4185-1)
FELBAMATE felbamate TABLET;ORAL 207093 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-4185 51672-4185-5 90 TABLET in 1 BOTTLE (51672-4185-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 20, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Apr 20, 2017TE:ABRLD:No

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