FDA Product

Fluocinonide

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

Basic Information

Product Name

Fluocinonide

FDA Product Code

71085-006

Regulatory Information

NDC Product Code

71085-006

Application Number

ANDA074799

Marketing Category

C73584

Effective Date

March 1, 2017

Territorial Authority

USA

FDA Title

Fluocinonide Topical Solution USP, 0.05%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerIPG PHARMACEUTICALS, INC.

DUNS Number

080441238

Active Ingredients

Quantity: 0.5 mg in 1 mL

Code: 2W4A77YPAN

Class Code: ACTIB

citric acid monohydrate

Code: 2968PHW8QP

Class Code: IACT

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

water

Code: 059QF0KO0R

Class Code: IACT

alcohol

Code: 3K9958V90M

Class Code: IACT

diisopropyl adipate

Code: P7E6YFV72X

Class Code: IACT

Active Moieties

Fluocinonide

Code: 2W4A77YPAN

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