Irinotecan Hydrochloride

ANDA 78188, held by Fresenius Kabi USA. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 78188 (Irinotecan Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Feb 27, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

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

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Mar 16, 2011	Supplement 5Labeling	Approved	None posted
Jun 21, 2010	Supplement 2Labeling	Approved	None posted
May 26, 2009	Supplement 4Labeling	Approved	None posted
Feb 27, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78188
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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