Eldecort

ANDA 80459, held by Valeant Pharm Intl. Hydrocortisone.

As of Nov 13, 2026, ANDA 80459 (Eldecort), held by Valeant Pharm Intl, was not approved, with 3 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 3
Complete response letters: 0

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eldecort1% · cream;topical	Hydrocortisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 28, 1984	Supplement 9Manufacturing	Approved	None posted
Sep 12, 1984	Supplement 8Manufacturing	Approved	None posted
Jul 1, 1982	Supplement 6Manufacturing	Approved	None posted

Identifiers

Application: ANDA 80459
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

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