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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 040253

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NDA 040253 describes ETHOSUXIMIDE, which is a drug marketed by Bionpharma, Epic Pharma Llc, Heritage Pharms Inc, Puracap Pharm Llc, Strides Pharma, Mikart, 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 040253

Tradename:	ETHOSUXIMIDE
Applicant:	Pharm Assoc
Ingredient:	ethosuximide
Patents:	0

Pharmacology for NDA: 040253

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040253

Anticonvulsants

Suppliers and Packaging for NDA: 040253

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ETHOSUXIMIDE	ethosuximide	SYRUP;ORAL	040253	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0670	0121-0670-16	473 mL in 1 BOTTLE (0121-0670-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	250MG/5ML
Approval Date:	Nov 22, 2000	TE:	AA	RLD:	No

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