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Last Updated: September 16, 2021

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Details for New Drug Application (NDA): 077651

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NDA 077651 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 077651
Applicant:Glenmark Generics
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077651
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 077651 ANDA Direct_Rx 61919-775 61919-775-30 30 CAPSULE in 1 BOTTLE (61919-775-30)
ZONISAMIDE zonisamide CAPSULE;ORAL 077651 ANDA Direct_Rx 61919-775 61919-775-90 90 CAPSULE in 1 BOTTLE (61919-775-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jan 30, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 30, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 30, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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