MedPath

Zonisamide

Rx Only

Approved
Approval ID

0c160018-e3fb-4f04-9475-c4cf2cceb1b7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2012

Manufacturers
FDA

Camber Pharmaceuticals

DUNS: 826774775

Products 1

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

Zonisamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-228
Application NumberANDA077869
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zonisamide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification

INGREDIENTS (6)

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

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Zonisamide - FDA Drug Approval Details