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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 077634


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NDA 077634 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Epic Pharma Llc, Glenmark Pharms Inc, Granules, Invagen Pharms, Macleods Pharms Ltd, Pharmobedient, Rising, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, Upsher Smith Labs, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty 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-two suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 077634
Tradename:ZONISAMIDE
Applicant:Sun Pharm Inds (in)
Ingredient:zonisamide
Patents:0
Pharmacology for NDA: 077634
Mechanism of ActionCarbonic Anhydrase Inhibitors
P-Glycoprotein Inhibitors
Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity
Suppliers and Packaging for NDA: 077634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 077634 ANDA Sun Pharmaceutical Industries, Inc. 62756-258 62756-258-01 30 CAPSULE in 1 BOTTLE (62756-258-01)
ZONISAMIDE zonisamide CAPSULE;ORAL 077634 ANDA Sun Pharmaceutical Industries, Inc. 62756-258 62756-258-02 100 CAPSULE in 1 BOTTLE (62756-258-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 17, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 17, 2006TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 17, 2006TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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