Irinotecan Hydrochloride

ANDA 90101, held by Teva Pharms USA. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 90101 (Irinotecan Hydrochloride), held by Teva Pharms USA, was first approved by FDA on Nov 26, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 26, 2008	Original application	Approved	None posted

Products

3 strengths and forms


Irinotecan Hydrochloride500MG/25ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Discontinued
Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 29, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Apr 29, 2013	Supplement 18Labeling · Standard review	Approved	None posted
Nov 26, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 90101
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals 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