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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077641


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NDA 077641 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Glenmark Generics, Granules, Heritage Pharma Avet, Invagen Pharms, Mylan Pharms Inc, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, and Zydus Lifesciences, and is included in eighteen NDAs. It is available from eighteen suppliers. Additional details are available on the ZONISAMIDE profile page.

The generic ingredient in ZONISAMIDE is zonisamide. There are nineteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 077641
Tradename:ZONISAMIDE
Applicant:Ani Pharms
Ingredient:zonisamide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 22, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 22, 2005TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 22, 2005TE:RLD:No

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