Hydrocortisone

ANDA 83365, held by Hikma. Hydrocortisone.

As of Nov 13, 2026, ANDA 83365 (Hydrocortisone), held by Hikma, was first approved by FDA on Jun 18, 1973, with 31 approved supplements and 0 published complete response letters.

First approved: Jun 18, 1973
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Jun 18, 1973	Original application	Approved	None posted

Products

3 strengths and forms


Hydrocortisone20MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone5MG · tablet;oral	Hydrocortisone	Discontinued
Hydrocortisone10MG · tablet;oral	Hydrocortisone	Discontinued

All 32 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 48Labeling · Standard review	Approved	None posted
Nov 26, 2024	Supplement 47Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 46Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 45Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 43Labeling · Standard review	Approved	None posted
Jun 28, 2017	Supplement 41Labeling · Standard review	Approved	None posted
Feb 23, 2015	Supplement 40Labeling	Approved	None posted
Feb 13, 2015	Supplement 42Labeling · Standard review	Approved	None posted
Jul 15, 2002	Supplement 36Manufacturing	Approved	None posted
Jan 16, 2002	Supplement 35Manufacturing	Approved	None posted
Aug 1, 2000	Supplement 34Manufacturing	Approved	None posted
Jan 21, 1999	Supplement 33Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 32Manufacturing	Approved	None posted
Nov 7, 1997	Supplement 31Manufacturing	Approved	None posted
Jun 8, 1995	Supplement 30Labeling	Approved	None posted
May 23, 1994	Supplement 29Labeling	Approved	None posted
Apr 22, 1994	Supplement 28Manufacturing	Approved	None posted
Apr 3, 1991	Supplement 23Manufacturing	Approved	None posted
Apr 3, 1991	Supplement 22Manufacturing	Approved	None posted
Mar 5, 1991	Supplement 24Labeling	Approved	None posted
Apr 9, 1990	Supplement 49Labeling	Approved	None posted
Apr 9, 1990	Supplement 19Labeling	Approved	None posted
Oct 14, 1988	Supplement 18Manufacturing	Approved	None posted
Oct 14, 1988	Supplement 16Manufacturing	Approved	None posted
Oct 14, 1988	Supplement 14Manufacturing	Approved	None posted
Jan 7, 1988	Supplement 20Manufacturing	Approved	None posted
Dec 5, 1986	Supplement 17Manufacturing	Approved	None posted
Nov 13, 1985	Supplement 11Manufacturing	Approved	None posted
Nov 13, 1985	Supplement 10Manufacturing	Approved	None posted
Jul 13, 1982	Supplement 9Manufacturing	Approved	None posted
Jul 13, 1982	Supplement 5Manufacturing	Approved	None posted
Jun 18, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 83365
Drugs@FDA: Overview at FDA
Company: Hikma

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