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Fluocinolone Acetonide

Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil)

Approved
Approval ID

fa5eba5b-57bf-4d46-b0e1-c7104542cb46

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 Code70752-158
Application NumberANDA212761
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

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Fluocinolone Acetonide - FDA Drug Approval Details