FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide Oil, 0.01% (Ear Drops)
Approved
Approval ID
2bcea813-d629-42c5-8953-fa231b4cbf58
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 Code70752-159
Application NumberANDA212762
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateFebruary 26, 2023
FDA Product Classification
INGREDIENTS (1)
FLUOCINOLONE ACETONIDEActive
Quantity: 0.11 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 2/26/2023
For Otic Use Only
Not for Ophthalmic Use