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Cipla
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Julphar
Fuji
Dow
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077625

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NDA 077625 describes ZONISAMIDE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, 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 077625
Tradename:ZONISAMIDE
Applicant:Zydus Pharms Usa
Ingredient:zonisamide
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONISAMIDE zonisamide CAPSULE;ORAL 077625 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-212 N 68382-212-01
ZONISAMIDE zonisamide CAPSULE;ORAL 077625 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-212 N 68382-212-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Oct 16, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Oct 16, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 16, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
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McKinsey
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Merck
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Colorcon
Cantor Fitzgerald
Queensland Health

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