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Last Updated: September 22, 2020

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Details for New Drug Application (NDA): 077634

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NDA 077634 describes ZONISAMIDE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Celltrion, Epic Pharma Llc, Glenmark Generics, Heritage Pharma, Invagen Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Upsher Smith Labs, and Zydus Pharms Usa, and is included in seventeen 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. Nineteen 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
Formulation / Manufacturing:see details
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 Lake Erie Medical DBA Quality Care Products LLC 35356-143 35356-143-30 30 CAPSULE in 1 BOTTLE (35356-143-30)
ZONISAMIDE zonisamide CAPSULE;ORAL 077634 ANDA PD-Rx Pharmaceuticals, Inc. 43063-932 43063-932-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-932-30)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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