Details for New Drug Application (NDA): 012806

NDA 012806 describes CORDRAN, which is a drug marketed by Almirall and Lilly and is included in five NDAs. It is available from two suppliers. Additional details are available on the CORDRAN profile page.

The generic ingredient in CORDRAN is flurandrenolide; neomycin sulfate. There are four drug master file entries for this compound. Additional details are available on the flurandrenolide; neomycin sulfate profile page.

Summary for 012806

Tradename:	CORDRAN
Applicant:	Almirall
Ingredient:	flurandrenolide
Patents:	0

Pharmacology for NDA: 012806

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 012806

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CORDRAN SP	flurandrenolide	CREAM;TOPICAL	012806	NDA	Almirall, LLC	16110-035	16110-035-12	1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE
CORDRAN	flurandrenolide	OINTMENT;TOPICAL	012806	NDA	Almirall, LLC	16110-035	16110-035-12	1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.05%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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