Irinotecan Hydrochloride

ANDA 206935, held by Ingenus Pharms LLC. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 206935 (Irinotecan Hydrochloride), held by Ingenus Pharms LLC, was first approved by FDA on May 26, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: May 26, 2017
Review: Standard
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
May 26, 2017	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 20, 2024	Supplement 8Labeling · Standard review	Approved	None posted
May 21, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 21, 2020	Supplement 6Labeling · Standard review	Approved	None posted
May 26, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206935
Drugs@FDA: Overview at FDA
Company: Ingenus Pharmaceuticals

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