FDA Product

Flurandrenolide

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

Basic Information

Product Name

Flurandrenolide

FDA Product Code

52565-017

Regulatory Information

NDC Product Code

52565-017

Application Number

ANDA207851

Marketing Category

C73584

Effective Date

September 10, 2019

Territorial Authority

USA

FDA Title

FLURANDRENOLIDE OINTMENT USP, 0.05%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerTeligent Pharma, Inc.

DUNS Number

011036910

Active Ingredients

White Wax

Code: 7G1J5DA97F

Class Code: IACT

Flurandrenolide

Quantity: 0.5 mg in 1 g

Code: 8EUL29XUQT

Class Code: ACTIB

Cetyl Alcohol

Code: 936JST6JCN

Class Code: IACT

Sorbitan Sesquioleate

Code: 0W8RRI5W5A

Class Code: IACT

Petrolatum

Code: 4T6H12BN9U

Class Code: IACT

Active Moieties

Flurandrenolide

Code: 8EUL29XUQT

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