Hydrocortisone

ANDA 40247, held by Sun Pharma Canada. Hydrocortisone.

As of Nov 13, 2026, ANDA 40247 (Hydrocortisone), held by Sun Pharma Canada, was first approved by FDA on Jul 23, 1999, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 23, 1999
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 23, 1999	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


Jun 24, 2005	Supplement 2Labeling	Approved	None posted
Jul 23, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 40247
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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