MedPath

Fluocinonide

0262 0263 0264

Approved
Approval ID

51cbe73c-e5d6-1e6a-e054-00144ff88e88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66267-973
Application NumberANDA072488
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 11, 2021
FDA Product Classification

INGREDIENTS (6)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
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

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Fluocinonide - FDA Drug Approval Details