Irinotecan Hydrochloride

For metastatic carcinoma of the colon or rectum. ANDA 78589, held by Actavis Totowa. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 78589 (Irinotecan Hydrochloride), held by Actavis Totowa, was first approved by FDA on Feb 27, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2008
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Irinotecan Hydrochloride Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan Hydrochloride Injection is a topoisomerase inhibitor indicated for: First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 27, 2008	Original application	Approved	None posted

Products

3 strengths and forms


Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride500MG/25ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx

All 9 submissions, including labeling and manufacturing supplements


May 16, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 18, 2015	Supplement 2Labeling	Approved	None posted
Aug 25, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Aug 25, 2015	Supplement 5Labeling	Approved	None posted
Nov 18, 2011	Supplement 3Labeling	Approved	None posted
Feb 27, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78589
Drugs@FDA: Overview at FDA
Company: Actavis Totowa

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