Cetacort

ANDA 80426, held by Bausch. Hydrocortisone.

As of Nov 13, 2026, ANDA 80426 (Cetacort), held by Bausch, was first approved by FDA on Dec 22, 1971, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1971
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 22, 1971	Original application	Approved	None posted

Products

2 strengths and forms


Cetacort1% · lotion;topical	Hydrocortisone	Discontinued
Cetacort0.5% · lotion;topical	Hydrocortisone	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Oct 20, 1998	Supplement 11Manufacturing	Approved	None posted
Jul 19, 1994	Supplement 10Labeling	Approved	None posted
Mar 18, 1992	Supplement 9Labeling	Approved	None posted
Apr 23, 1991	Supplement 8Manufacturing	Approved	None posted
Apr 23, 1991	Supplement 7Manufacturing	Approved	None posted
Oct 29, 1985	Supplement 6Manufacturing	Approved	None posted
Nov 4, 1982	Supplement 4Manufacturing	Approved	None posted
Dec 22, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 80426
Drugs@FDA: Overview at FDA
Company: Bausch Health

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