Nutracort

ANDA 80443, held by Dow Pharm. Hydrocortisone.

As of Nov 13, 2026, ANDA 80443 (Nutracort), held by Dow Pharm, was first approved by FDA on Apr 26, 1972, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1972
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 26, 1972	Original application	Approved	None posted

Products

2 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Jul 15, 2002	Supplement 32Manufacturing	Approved	None posted
Oct 23, 2001	Supplement 31Manufacturing	Approved	None posted
Aug 17, 1998	Supplement 1Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 30Labeling	Approved	None posted
Feb 11, 1991	Supplement 29Labeling	Approved	None posted
Nov 21, 1988	Supplement 23Manufacturing	Approved	None posted
Nov 21, 1988	Supplement 24Manufacturing	Approved	None posted
Nov 21, 1988	Supplement 25Labeling	Approved	None posted
Jul 26, 1985	Supplement 26Manufacturing	Approved	None posted
Jan 25, 1983	Supplement 21Manufacturing	Approved	None posted
Apr 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80443
Drugs@FDA: Overview at FDA
Company: Dow Pharm

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