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
NDC Product Code70752-159
Application NumberANDA212762
Marketing CategoryC73584
Route of AdministrationAURICULAR (OTIC)
Effective DateFebruary 26, 2023
Generic Namefluocinolone acetonide
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