Irinotecan Hydrochloride

ANDA 90675, held by Hengrui Pharma. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 90675 (Irinotecan Hydrochloride), held by Hengrui Pharma, was first approved by FDA on Dec 16, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 16, 2011
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Dec 16, 2011	Original application	Approved	None posted
Dec 16, 2011	Supplement 18Efficacy (new indication or use)	Approved	None posted

Products

2 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


May 23, 2025	Supplement 5Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 10Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 11Labeling · Standard review	Approved	None posted
May 23, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Apr 29, 2013	Supplement 1Labeling	Approved	None posted
Dec 16, 2011	Original application	Approved	None posted
Dec 16, 2011	Supplement 16Labeling	Approved	None posted
Dec 16, 2011	Supplement 17Labeling	Approved	None posted
Dec 16, 2011	Supplement 18Efficacy (new indication or use)	Approved	None posted
Dec 16, 2011	Supplement 19Labeling	Approved	None posted

Identifiers

Application: ANDA 90675
Drugs@FDA: Overview at FDA
Company: Hengrui Pharma

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