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Details for New Drug Application (NDA): 081306

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NDA 081306 describes ETHOSUXIMIDE, which is a drug marketed by Mikart, Teva Pharms, Bionpharma Inc, Pharm Assoc, Versapharm, and Heritage Pharms Inc, and is included in six 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 NDA: 081306

Teva Pharms
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 081306

Suppliers and Packaging for NDA: 081306

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYRUP;ORAL 081306 ANDA Teva Pharmaceuticals USA, Inc. 0093-9660 0093-9660-16 474 mL in 1 BOTTLE (0093-9660-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Jul 30, 1993TE:AARLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.