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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020789

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NDA 020789 describes ZONEGRAN, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ZONEGRAN profile page.

The generic ingredient in ZONEGRAN 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 020789
Applicant:Sunovion Pharms Inc
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020789
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONEGRAN zonisamide CAPSULE;ORAL 020789 NDA Concordia Pharmaceuticals Inc. 59212-680 59212-680-10 100 CAPSULE in 1 BOTTLE (59212-680-10)
ZONEGRAN zonisamide CAPSULE;ORAL 020789 NDA Concordia Pharmaceuticals Inc. 59212-681 59212-681-10 100 CAPSULE in 1 BOTTLE (59212-681-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 27, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 22, 2003TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Aug 22, 2003TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

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