KETOCONAZOLE
KETOCONAZOLE TABLETS USP, 200 mg0900
Approved
Approval ID
d9dd50aa-e8d9-4839-ae92-26135415357e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 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.
KETOCONAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-998
Application NumberANDA075273
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2011
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
KETOCONAZOLEActive
Quantity: 200 mg in 1 1
Code: R9400W927I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT