Hydrocortisone

ANDA 86155, held by Taro. Hydrocortisone.

As of Nov 13, 2026, ANDA 86155 (Hydrocortisone), held by Taro, was first approved by FDA on Jul 24, 1978, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1978
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 24, 1978	Original application	Approved	None posted

Products

1 strengths and forms

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

All 23 submissions, including labeling and manufacturing supplements


Apr 28, 2005	Supplement 42Labeling	Approved	None posted
Jun 20, 2001	Supplement 39Manufacturing	Approved	None posted
Apr 29, 1993	Supplement 36Labeling	Approved	None posted
Nov 23, 1992	Supplement 35Labeling	Approved	None posted
Nov 16, 1992	Supplement 34Labeling	Approved	None posted
Jan 23, 1991	Supplement 32Labeling	Approved	None posted
Jan 3, 1991	Supplement 31Manufacturing	Approved	None posted
Dec 15, 1989	Supplement 29Labeling	Approved	None posted
Nov 13, 1989	Supplement 28Labeling	Approved	None posted
Jul 31, 1989	Supplement 27Manufacturing	Approved	None posted
Apr 26, 1989	Supplement 26Labeling	Approved	None posted
Jan 8, 1987	Supplement 20Manufacturing	Approved	None posted
Jan 10, 1986	Supplement 18Manufacturing	Approved	None posted
Nov 13, 1985	Supplement 17Manufacturing	Approved	None posted
Oct 2, 1984	Supplement 16Manufacturing	Approved	None posted
Jul 3, 1984	Supplement 12Manufacturing	Approved	None posted
Aug 18, 1983	Supplement 13Manufacturing	Approved	None posted
Jul 9, 1982	Supplement 11Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 8Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 4Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 3Manufacturing	Approved	None posted
Jun 2, 1982	Supplement 2Manufacturing	Approved	None posted
Jul 24, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 86155
Drugs@FDA: Overview at FDA
Company: Taro 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