Irinotecan Hydrochloride

ANDA 90137, held by Sandoz. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 90137 (Irinotecan Hydrochloride), held by Sandoz, was first approved by FDA on Nov 12, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 12, 2009
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
Nov 12, 2009	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 16, 2011	Supplement 1Labeling	Approved	None posted
Nov 12, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90137
Drugs@FDA: Overview at FDA
Company: Sandoz

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