Hytone

ANDA 80474, held by Dermik Labs. Hydrocortisone.

As of Nov 13, 2026, ANDA 80474 (Hytone), held by Dermik Labs, was first approved by FDA on Sep 26, 1972, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 26, 1972
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
Sep 26, 1972	Original application	Approved	None posted

Products

2 strengths and forms


Hytone1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Hydrocortisone	DiscontinuedReference drug
Hytone2.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Hydrocortisone	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Dec 9, 1991	Supplement 22Labeling	Approved	None posted
Sep 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80474
Drugs@FDA: Overview at FDA
Company: Dermik Laboratories

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