Irinotecan Hydrochloride

ANDA 77219, held by Cipla Ltd. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 77219 (Irinotecan Hydrochloride), held by Cipla Ltd, was first approved by FDA on Feb 20, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 20, 2008
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 20, 2008	Original application	Approved	Letter

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 8 submissions, including labeling and manufacturing supplements


Mar 15, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Jun 19, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jun 19, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Oct 7, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Oct 7, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Apr 29, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Jan 24, 2013	Supplement 2Labeling	Approved	None posted
Feb 20, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 77219
Drugs@FDA: Overview at FDA
Company: Cipla

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