FDA Product

Cordran

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

Basic Information

Product Name

Cordran

FDA Product Code

16110-052

Regulatory Information

NDC Product Code

16110-052

Application Number

NDA013790

Marketing Category

C73594

Effective Date

July 5, 2018

Territorial Authority

USA

FDA Title

Cordran® Lotion, 0.05% Flurandrenolide Lotion, 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 mL

Code: 8EUL29XUQT

Class Code: ACTIB

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

POLYOXYL 40 STEARATE

Code: 13A4J4NH9I

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

MENTHOL

Code: L7T10EIP3A

Class Code: IACT

Active Moieties

FLURANDRENOLIDE

Code: 8EUL29XUQT

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