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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 040253

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NDA 040253 describes ETHOSUXIMIDE, which is a drug marketed by Akorn, Bionpharma Inc, Heritage Pharms Inc, Puracap Pharm Llc, Strides Pharma, Mikart, Pharm Assoc, and Teva Pharms, and is included in eight NDAs. It is available from nine 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. Eleven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 040253
Medical Subject Heading (MeSH) Categories for 040253
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 Pharmaceutical Associates, Inc. 0121-0670 0121-0670-16 473 mL in 1 BOTTLE (0121-0670-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Nov 22, 2000TE:AARLD:No

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