Stie-Cort

ANDA 89066, held by Padagis US. Hydrocortisone.

As of Nov 14, 2026, ANDA 89066 (Stie-Cort), held by Padagis US, was first approved by FDA on Nov 25, 1985, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1985
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 25, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Stie-Cort1% · lotion;topical	Hydrocortisone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 28, 2007	Supplement 13Labeling	Approved	None posted
Aug 16, 2001	Supplement 12Manufacturing	Approved	None posted
Aug 3, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 22, 1996	Supplement 10Manufacturing	Approved	None posted
Apr 14, 1995	Supplement 9Manufacturing	Approved	None posted
May 14, 1986	Supplement 2Manufacturing	Approved	None posted
May 14, 1986	Supplement 1Manufacturing	Approved	None posted
Apr 11, 1986	Supplement 4Manufacturing	Approved	None posted
Nov 25, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 89066
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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