Nutracort

ANDA 87644, held by Dow Pharm. Hydrocortisone.

As of Nov 13, 2026, ANDA 87644 (Nutracort), held by Dow Pharm, was first approved by FDA on Aug 24, 1982, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 24, 1982
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 24, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nutracort2.5% · lotion;topical	Hydrocortisone	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 15, 2002	Supplement 14Manufacturing	Approved	None posted
Jul 15, 2002	Supplement 13Manufacturing	Approved	None posted
Jul 15, 2002	Supplement 12Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 11Labeling	Approved	None posted
Nov 16, 1998	Supplement 10Manufacturing	Approved	None posted
Aug 25, 1998	Supplement 9Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 8Labeling	Approved	None posted
Mar 15, 1991	Supplement 7Labeling	Approved	None posted
Feb 1, 1991	Supplement 6Labeling	Approved	None posted
Aug 24, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87644
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