FDA Product

Flurandrenolide

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

Basic Information

Product Name

Flurandrenolide

FDA Product Code

51672-5301

Regulatory Information

NDC Product Code

51672-5301

Application Number

NDA012806

Marketing Category

C73594

Effective Date

April 28, 2016

Territorial Authority

USA

FDA Title

Flurandrenolide Cream, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerTaro Pharmaceuticals U.S.A., Inc.

DUNS Number

145186370

Active Ingredients

Citric Acid Monohydrate

Code: 2968PHW8QP

Class Code: IACT

Polyoxyl 40 stearate

Code: 13A4J4NH9I

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Sodium Citrate, Unspecified Form

Code: 1Q73Q2JULR

Class Code: IACT

Stearic acid

Code: 4ELV7Z65AP

Class Code: IACT

Flurandrenolide

Quantity: 0.5 mg in 1 g

Code: 8EUL29XUQT

Class Code: ACTIB

Cetyl Alcohol

Code: 936JST6JCN

Class Code: IACT

Mineral oil

Code: T5L8T28FGP

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

Flurandrenolide

Code: 8EUL29XUQT

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