Hydrocortisone

ANDA 89705, held by Naska. Hydrocortisone.

As of Nov 13, 2026, ANDA 89705 (Hydrocortisone), held by Naska, was first approved by FDA on Apr 25, 1988, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 25, 1988
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
Apr 25, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · lotion;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 22, 1988	Supplement 1Labeling	Approved	None posted
Apr 25, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89705
Drugs@FDA: Overview at FDA
Company: NASKA

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