FDA Product

Fluocinonide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Fluocinonide

FDA Product Code

47781-569

Regulatory Information

NDC Product Code

47781-569

Application Number

NDA016909

Marketing Category

C73594

Effective Date

October 2, 2017

Territorial Authority

USA

FDA Title

Fluocinonide Ointment, 0.05%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

15

Company Information

ManufacturerAlvogen Inc.

DUNS Number

008057330

Active Ingredients

Quantity: 0.5 mg in 1 g

Code: 2W4A77YPAN

Class Code: ACTIB

Petrolatum

Code: 4T6H12BN9U

Class Code: IACT

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

White Wax

Code: 7G1J5DA97F

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Propylene Carbonate

Code: 8D08K3S51E

Class Code: IACT

Active Moieties

Fluocinonide

Code: 2W4A77YPAN

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