MedPath

Fluocinonide

026202630264

Approved
Approval ID

d0a13050-3266-4ccd-bfc9-7fe1de28aa24

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluocinonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-2419
Application NumberANDA072488
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 6, 2022
FDA Product Classification

INGREDIENTS (6)

1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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Fluocinonide - FDA Drug Approval Details