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Generated: April 30, 2017

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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 Bionpharma Inc, Zydus Pharms Usa, Sun Pharm Inds (in), Sun Pharm Inds, Wockhardt, Mylan, Ani Pharms Inc, Apotex Inc, Upsher-smith Labs, Dr Reddys Labs Ltd, Mylan Pharms Inc, Roxane, Watson Labs, Glenmark Generics, Invagen Pharms, and Corepharma, and is included in seventeen NDAs. It is available from twenty-nine suppliers. Additional details are available on the ZONISAMIDE profile page.

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

Summary for NDA: 077651

Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077651

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 077651 ANDA A-S Medication Solutions 50090-2174 50090-2174-0 60 CAPSULE in 1 BOTTLE (50090-2174-0)
CAPSULE;ORAL 077651 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-325 55700-325-30 30 CAPSULE in 1 BOTTLE (55700-325-30)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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