Hydrocortisone

ANDA 40351, held by Fougera Pharms. Hydrocortisone.

As of Nov 13, 2026, ANDA 40351 (Hydrocortisone), held by Fougera Pharms, was first approved by FDA on Jul 25, 2000, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 25, 2000
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 25, 2000	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone2.5% · lotion;topical	Hydrocortisone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 7, 2001	Supplement 1Manufacturing	Approved	None posted
Jul 25, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 40351
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

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