Irinotecan Hydrochloride

ANDA 78953, held by Chartwell Rx. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 78953 (Irinotecan Hydrochloride), held by Chartwell Rx, was first approved by FDA on Apr 15, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 15, 2010
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Apr 15, 2010	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 2 submissions, including labeling and manufacturing supplements


Mar 14, 2011	Supplement 1Labeling	Approved	None posted
Apr 15, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78953
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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