Irinotecan Hydrochloride

For metastatic carcinoma of the colon or rectum. ANDA 91032, held by Hikma Farmaceutica. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 91032 (Irinotecan Hydrochloride), held by Hikma Farmaceutica, was first approved by FDA on Dec 20, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 20, 2010
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Irinotecan Hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 20, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Jan 2, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Dec 20, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91032
Drugs@FDA: Overview at FDA
Company: Hikma Farmacêutica

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