Irinotecan Hydrochloride

ANDA 200771, held by Emcure Pharms Ltd. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 200771 (Irinotecan Hydrochloride), held by Emcure Pharms Ltd, was first approved by FDA on Feb 14, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 14, 2012
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 14, 2012	Original application	Approved	Review

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 24, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Feb 14, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 200771
Drugs@FDA: Overview at FDA
Company: Emcure 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