Fluocinolone Acetonide
Fluocinolone Acetonide Topical Solution USP, 0.01%
Approved
Approval ID
270961cf-7ccb-4291-be16-87ce3196b200
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.
Fluocinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71428-002
Application NumberANDA209596
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (3)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FLUOCINOLONE ACETONIDEActive
Quantity: 0.1 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB