Hydrocortisone

ANDA 80489, held by Altana. Hydrocortisone.

As of Nov 13, 2026, ANDA 80489 (Hydrocortisone), held by Altana, was not approved, with 3 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 3
Complete response letters: 0

Products

2 strengths and forms


Hydrocortisone0.5% · ointment;topical	Hydrocortisone	Discontinued
Hydrocortisone1% · ointment;topical	Hydrocortisone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 12, 1982	Supplement 2Manufacturing	Approved	None posted
Jul 29, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 7, 1982	Supplement 7Manufacturing	Approved	None posted

Identifiers

Application: ANDA 80489
Drugs@FDA: Overview at FDA
Company: Altana

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