Nutracort

ANDA 84698, held by Healthpoint. Hydrocortisone.

As of Nov 13, 2026, ANDA 84698 (Nutracort), held by Healthpoint, was first approved by FDA on Jan 6, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 6, 1976
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 6, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nutracort1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;topical	Hydrocortisone	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Mar 13, 1992	Supplement 7Labeling	Approved	None posted
Jan 6, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84698
Drugs@FDA: Overview at FDA
Company: Healthpoint, Ltd.

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