Hydrocortisone

ANDA 87317, held by Alpharma US Pharms. Hydrocortisone.

As of Nov 13, 2026, ANDA 87317 (Hydrocortisone), held by Alpharma US Pharms, was first approved by FDA on Jun 7, 1982, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 7, 1982
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 7, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone0.5% · lotion;topical	Hydrocortisone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 8, 1989	Supplement 4Manufacturing	Approved	None posted
Feb 4, 1987	Supplement 2Manufacturing	Approved	None posted
Apr 1, 1986	Supplement 1Manufacturing	Approved	None posted
Jun 7, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87317
Drugs@FDA: Overview at FDA
Company: Alpharma US Pharmaceuticals

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