Nutracort

ANDA 80442, held by Bausch. Hydrocortisone.

As of Nov 13, 2026, ANDA 80442 (Nutracort), held by Bausch, was first approved by FDA on Apr 4, 1972, with 13 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1972
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Apr 4, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Nutracort0.5% · cream;topical	Hydrocortisone	Discontinued
Nutracort1% · cream;topical	Hydrocortisone	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 25, 1994	Supplement 47Labeling	Approved	None posted
Feb 1, 1991	Supplement 46Labeling	Approved	None posted
Dec 23, 1985	Supplement 42Manufacturing	Approved	None posted
Dec 23, 1985	Supplement 41Manufacturing	Approved	None posted
Nov 15, 1985	Supplement 44Manufacturing	Approved	None posted
Mar 26, 1985	Supplement 40Manufacturing	Approved	None posted
Mar 26, 1985	Supplement 38Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 33Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 31Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 30Manufacturing	Approved	None posted
Jul 18, 1984	Supplement 35Manufacturing	Approved	None posted
Jul 18, 1984	Supplement 34Manufacturing	Approved	None posted
Oct 22, 1982	Supplement 28Manufacturing	Approved	None posted
Apr 4, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80442
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