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Fluocinonide

Approved
Approval ID

18250b3f-8c5f-4623-9617-62c298458871

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 8, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-2451
Application NumberANDA074799
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification

INGREDIENTS (5)

DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 mL
Code: 2W4A77YPAN
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

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Fluocinonide - FDA Drug Approval Details