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Fluocinonide Cream

Fluocinonide Cream USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only

Approved
Approval ID

33601219-6ffc-4cc3-b911-fe85a5555f90

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2023

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

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

Fluocinonide

PRODUCT DETAILS

NDC Product Code68788-8105
Application NumberANDA210554
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJune 8, 2023
Generic NameFluocinonide

INGREDIENTS (8)

FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT

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Fluocinonide Cream - FDA Drug Approval Details