Oxiconazole Nitrate
Approved
Approval ID
04477378-cccc-4db3-9e1b-5c1d6a00bd13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxiconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1359
Application NumberANDA205076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxiconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (8)
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
Oxiconazole NitrateActive
Quantity: 10 mg in 1 g
Code: RQ8UL4C17S
Classification: ACTIM
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT