Hydrocortisone

ANDA 80400, held by Teva. Hydrocortisone.

As of Nov 13, 2026, ANDA 80400 (Hydrocortisone), held by Teva, was first approved by FDA on Sep 15, 1972, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1972
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 15, 1972	Original application	Approved	None posted

Products

3 strengths and forms


Hydrocortisone0.5% · cream;topical	Hydrocortisone	Discontinued
Hydrocortisone1% · cream;topical	Hydrocortisone	Discontinued
Hydrocortisone2.5% · cream;topical	Hydrocortisone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jul 1, 1988	Supplement 33Manufacturing	Approved	None posted
Jul 1, 1988	Supplement 34Manufacturing	Approved	None posted
Jul 29, 1986	Supplement 31Manufacturing	Approved	None posted
Jul 29, 1986	Supplement 32Manufacturing	Approved	None posted
Feb 22, 1985	Supplement 27Manufacturing	Approved	None posted
Mar 8, 1984	Supplement 26Manufacturing	Approved	None posted
Oct 5, 1983	Supplement 22Manufacturing	Approved	None posted
Mar 3, 1982	Supplement 18Manufacturing	Approved	None posted
Sep 15, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80400
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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