Fluocinonide
Fluocinonide Topical Solution USP, 0.05%
Approved
Approval ID
67c20067-bc86-4ec0-9a3c-01ea316e9c16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Glasshouse Pharmaceuticals Limited Canada
DUNS: 203493598
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71428-001
Application NumberANDA209118
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 mL
Code: 2W4A77YPAN
Classification: ACTIB