Irinotecan Hydrochloride

ANDA 77260, held by Teva Parenteral. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 77260 (Irinotecan Hydrochloride), held by Teva Parenteral, was first approved by FDA on Feb 27, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 27, 2008
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
Feb 27, 2008	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Nov 22, 2011	Supplement 11Labeling	Approved	None posted
Feb 27, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77260
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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