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Last Updated: October 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214492


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NDA 214492 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 nineteen 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 214492
Tradename:ZONISAMIDE
Applicant:Unichem
Ingredient:zonisamide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 214492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 214492 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-428 29300-428-01 100 CAPSULE in 1 BOTTLE (29300-428-01)
ZONISAMIDE zonisamide CAPSULE;ORAL 214492 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-428 29300-428-05 500 CAPSULE in 1 BOTTLE (29300-428-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jan 26, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 26, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 26, 2021TE:ABRLD:No

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