Irinotecan Hydrochloride

For metastatic carcinoma of the colon or rectum. ANDA 203380, held by Qilu Pharm Hainan. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 203380 (Irinotecan Hydrochloride), held by Qilu Pharm Hainan, was first approved by FDA on May 3, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: May 3, 2016
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
May 3, 2016	Original application	Approved	Letter

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 Hydrochloride300MG/15ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 3, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 3Labeling · Standard review	Approved	None posted
May 3, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 203380
Drugs@FDA: Overview at FDA
Company: Qilu Pharmaceutical (Hainan)

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