Oxistat
OXISTAT (oxiconazole nitrate) Lotion, 1%*
Approved
Approval ID
64ef2286-0f56-4a8a-b07b-4a597f078ae0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2022
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
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 Code62559-285
Application NumberNDA020209
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxiconazole nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 23, 2022
FDA Product Classification
INGREDIENTS (8)
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
oxiconazole nitrateActive
Quantity: 10 mg in 1 mL
Code: RQ8UL4C17S
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT