Irinotecan Hydrochloride

ANDA 203054, held by Intas Pharms USA. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 203054 (Irinotecan Hydrochloride), held by Intas Pharms USA, was first approved by FDA on Aug 31, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 2017
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
Aug 31, 2017	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


May 2, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Aug 31, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203054
Drugs@FDA: Overview at FDA
Company: Intas 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