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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202385

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NDA 202385 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 202385

Tradename:	FELBAMATE
Applicant:	Amneal Pharms
Ingredient:	felbamate
Patents:	0

Pharmacology for NDA: 202385

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

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:	RX	Dosage:	SUSPENSION;ORAL			Strength	600MG/5ML
Approval Date:	Dec 16, 2011	TE:	AB	RLD:	No

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