Ketodan
These highlights do not include all the information needed to use KETODAN FOAM safely and effectively. See full prescribing information for KETODAN FOAM. KETODAN (KETOCONAZOLE) Foam, 2% For topical use Initial U.S. Approval: 1981
Approved
Approval ID
62f19bd8-926e-4e6b-9097-d81b894b95cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals, Inc.
DUNS: 019903816
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 Code43538-530
Application NumberANDA091550
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketoconazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (13)
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
ketoconazoleActive
Quantity: 20 mg in 1 g
Code: R9400W927I
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
tert-butyl alcoholInactive
Code: MD83SFE959
Classification: IACT
brucine sulfateInactive
Code: KY7O12XPOQ
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
potassium citrateInactive
Code: EE90ONI6FF
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
propaneInactive
Code: T75W9911L6
Classification: IACT
butaneInactive
Code: 6LV4FOR43R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT