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Last Updated: September 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077869

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NDA 077869 describes ZONISAMIDE, which is a drug marketed by Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Cadila, Epic Pharma Llc, Glenmark Generics, Granules, Heritage Pharma, Invagen Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Unichem, and Upsher Smith Labs, and is included in eighteen 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-one suppliers are listed for this compound. Additional details are available on the zonisamide profile page.
Summary for 077869
Applicant:Invagen Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077869
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 077869 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8266 0615-8266-39 30 CAPSULE in 1 BLISTER PACK (0615-8266-39)
ZONISAMIDE zonisamide CAPSULE;ORAL 077869 ANDA AvPAK 50268-816 50268-816-15 50 BLISTER PACK in 1 BOX (50268-816-15) > 1 CAPSULE in 1 BLISTER PACK (50268-816-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:May 31, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:May 31, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 31, 2006TE:ABRLD:No

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