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Zonisamide

Zonisamide Capsules USP Rx Only

Approved
Approval ID

b20a51ef-255e-1eb0-c0e1-461cde46b887

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2022

Manufacturers
FDA

AvPAK

DUNS: 832926666

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zonisamide

PRODUCT DETAILS

NDC Product Code50268-816
Application NumberANDA077869
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2022
Generic NameZonisamide

INGREDIENTS (6)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
ZONISAMIDEActive
Quantity: 100 mg in 1 1
Code: 459384H98V
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

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Zonisamide - FDA Drug Approval Details