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Fluocinonide

Fluocinonide Cream USP, 0.05%

Approved
Approval ID

8ac0ecd6-38b5-a5f9-e053-2a95a90af412

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 18, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-4921
Application NumberANDA071500
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateFebruary 18, 2021
Generic NameFluocinonide

INGREDIENTS (8)

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

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Fluocinonide - FDA Drug Approval Details