Colocort

Treats ulcerative colitis, especially distal forms … left-sided ulcerative colitis. ANDA 75172, held by Chartwell. Hydrocortisone.

As of Nov 13, 2026, ANDA 75172 (Colocort), held by Chartwell, was first approved by FDA on Dec 3, 1999, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1999
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 3, 1999	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Colocort100MG/60ML · enema;rectal	Hydrocortisone	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 23, 2008	Supplement 12Labeling	Approved	None posted
Jul 27, 2001	Supplement 2Manufacturing	Approved	None posted
May 8, 2000	Supplement 1Manufacturing	Approved	None posted
Dec 3, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75172
Drugs@FDA: Overview at FDA
Company: Chartwell

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