Fluocinolone Acetonide
Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil)
Approved
Approval ID
1159c5ff-426d-45b8-9fb4-51feb9b760c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-703
Application NumberANDA201759
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (6)
FLUOCINOLONE ACETONIDEActive
Quantity: 0.11 mg in 118.28 mL
Code: 0CD5FD6S2M
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0
Classification: IACT