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Serving leading biopharmaceutical companies globally:

Chubb
Colorcon
Cerilliant
Citi
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
UBS
Healthtrust
Federal Trade Commission

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077636

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NDA 077636 describes ZONISAMIDE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Bionpharma Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Generics, Invagen Pharms, Mylan, Mylan Pharms Inc, Roxane, Sun Pharm Inds (in), Sun Pharm Industries, Upsher-smith Labs, Watson Labs, Wockhardt, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-eight suppliers. Additional details are available on the ZONISAMIDE profile page.

The generic ingredient in ZONISAMIDE is zonisamide. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the zonisamide profile page.

Summary for 077636

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 077636 ANDA STAT RX USA LLC 16590-724 16590-724-30 30 CAPSULE in 1 BOTTLE (16590-724-30)
ZONISAMIDE zonisamide CAPSULE;ORAL 077636 ANDA STAT RX USA LLC 16590-724 16590-724-60 60 CAPSULE in 1 BOTTLE (16590-724-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 22, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 27, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 27, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Fish and Richardson
Cerilliant
QuintilesIMS
McKesson
UBS
Julphar

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