ZONISAMIDE
Approved
Approval ID
0ab183cf-51aa-402a-9351-53a4f112d1f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-724
Application NumberANDA077636
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZONISAMIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2011
FDA Product Classification
INGREDIENTS (8)
ZONISAMIDEActive
Quantity: 25 mg in 1 1
Code: 459384H98V
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT