Irinotecan Hydrochloride

ANDA 79068, held by Accord Hlthcare. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 79068 (Irinotecan Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Nov 21, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 21, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 21, 2008	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 3 submissions, including labeling and manufacturing supplements


May 9, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Mar 14, 2011	Supplement 1Labeling	Approved	None posted
Nov 21, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79068
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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