Cordran

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive…. NDA 16455, held by Almirall. Flurandrenolide.

As of Nov 13, 2026, NDA 16455 (Cordran), held by Almirall, was first approved by FDA on Jul 29, 1969, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1969
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jul 29, 1969	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cordran0.004MG/SQ CM · tape;topical	Flurandrenolide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 13, 2017	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 22, 2010	Supplement 24Manufacturing	Approved	None posted
Jul 19, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 6, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 23, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 18, 1987	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 19, 1987	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 3, 1987	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 20, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 6, 1982	Supplement 12Labeling	Approved	None posted
Nov 14, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 19, 1977	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 29, 1969	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16455
Drugs@FDA: Overview at FDA
Company: Almirall

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters