Cordran, Cordran Sp

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 12806, held by Ina Pharms. Flurandrenolide.

As of Nov 14, 2026, NDA 12806 (Cordran, Cordran Sp), held by Ina Pharms, was first approved by FDA on Oct 18, 1965, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 18, 1965
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cordran (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 18, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms


Cordran0.05% · ointment;topical	Flurandrenolide	DiscontinuedReference drug
Cordran Sp0.05% · cream;topical	Flurandrenolide	DiscontinuedReference drug
Cordran Sp0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Flurandrenolide	DiscontinuedReference drug
Cordran0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Flurandrenolide	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Jul 23, 2013	Supplement 37Manufacturing · Standard review	Approved	Label
Jun 12, 2013	Supplement 36Manufacturing · Standard review	Approved	Letter
Dec 14, 2012	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 25, 2008	Supplement 32Manufacturing	Approved	None posted
Jul 17, 2002	Supplement 28Manufacturing · Standard review	Approved	Letter
Nov 6, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 2, 1990	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 18, 1987	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 3, 1987	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 14, 1986	Supplement 22Labeling	Approved	None posted
Oct 8, 1982	Supplement 21Labeling	Approved	None posted
Aug 12, 1980	Supplement 20Labeling	Approved	None posted
Nov 26, 1979	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 24, 1978	Supplement 16Labeling	Approved	None posted
Jun 30, 1978	Supplement 17Labeling	Approved	None posted
Dec 14, 1977	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 11, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 23, 1977	Supplement 14Labeling	Approved	None posted
Oct 18, 1965	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12806
Drugs@FDA: Overview at FDA
Company: INA Pharms

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