FDA Product

Cordran

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

Basic Information

Product Name

Cordran

FDA Product Code

16110-035

Regulatory Information

NDC Product Code

16110-035

Application Number

NDA012806

Marketing Category

C73594

Effective Date

January 13, 2023

Territorial Authority

USA

FDA Title

Cordran Cream and Cordran Ointment Flurandrenolide, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

11

Company Information

ManufacturerAlmirall, LLC

DUNS Number

605425912

Active Ingredients

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

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

POLYOXYL 40 STEARATE

Code: 13A4J4NH9I

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

FLURANDRENOLIDE

Code: 8EUL29XUQT

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