Hydrocortisone

ANDA 85282, held by Mericon. Hydrocortisone.

As of Nov 14, 2026, ANDA 85282 (Hydrocortisone), held by Mericon, was first approved by FDA on Jun 5, 1978, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1978
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 5, 1978	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Nov 2, 1989	Supplement 14Labeling	Approved	None posted
Feb 26, 1987	Supplement 10Manufacturing	Approved	None posted
Feb 26, 1987	Supplement 11Manufacturing	Approved	None posted
Feb 26, 1987	Supplement 12Manufacturing	Approved	None posted
Jun 5, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85282
Drugs@FDA: Overview at FDA
Company: Mericon

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