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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210654

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NDA 210654 describes ETHOSUXIMIDE, which is a drug marketed by Bionpharma, Epic Pharma Llc, Heritage Pharms Inc, Onesource Specialty, Puracap Pharm Llc, Chartwell Rx, Pharm Assoc, and Teva Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the ETHOSUXIMIDE profile page.

The generic ingredient in ETHOSUXIMIDE is ethosuximide. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethosuximide profile page.

Summary for 210654

Tradename:	ETHOSUXIMIDE
Applicant:	Puracap Pharm Llc
Ingredient:	ethosuximide
Patents:	0

Pharmacology for NDA: 210654

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 210654

Anticonvulsants

Suppliers and Packaging for NDA: 210654

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	210654	ANDA	Epic Pharma, LLC	42806-708	42806-708-01	100 CAPSULE in 1 BOTTLE (42806-708-01)
ETHOSUXIMIDE	ethosuximide	CAPSULE;ORAL	210654	ANDA	Epic Pharma, LLC	42806-711	42806-711-01	100 CAPSULE in 1 BOTTLE (42806-711-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Mar 16, 2020	TE:	AB	RLD:	No

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