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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208970

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NDA 208970 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 208970

Tradename:	FELBAMATE
Applicant:	Zydus Lifesciences
Ingredient:	felbamate
Patents:	0

Pharmacology for NDA: 208970

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 208970

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FELBAMATE	felbamate	TABLET;ORAL	208970	ANDA	Zydus Lifesciences Limited	70771-1077	70771-1077-1	100 TABLET in 1 BOTTLE (70771-1077-1)
FELBAMATE	felbamate	TABLET;ORAL	208970	ANDA	Zydus Lifesciences Limited	70771-1077	70771-1077-3	30 TABLET in 1 BOTTLE (70771-1077-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 30, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	May 30, 2017	TE:	AB	RLD:	No

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