Fluocinolone Acetonide
These highlights do not include all the information needed to use FLUOCINOLONE ACETONIDE TOPICAL OIL safely and effectively. See full prescribing information for FLUOCINOLONE ACETONIDE TOPICAL OIL. FLUOCINOLONE ACETONIDE topical oil (body oil), for topical use only Not for oral, ophthalmic, or intravaginal use Initial U.S. Approval: 1988
Approved
Approval ID
a625fe98-8630-4b27-b2fc-4b045847d8f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2023
Manufacturers
FDA
Quagen Pharmaceuticals LLC
DUNS: 073645339
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 Code70752-156
Application NumberANDA212760
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 26, 2023
FDA Product Classification
INGREDIENTS (1)
fluocinolone acetonideActive
Quantity: 0.11 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB