Irinotecan Hydrochloride

ANDA 208718, held by Adaptis. Irinotecan Hydrochloride.

As of Nov 15, 2026, ANDA 208718 (Irinotecan Hydrochloride), held by Adaptis, was first approved by FDA on Dec 28, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 28, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 28, 2018	Original application	Approved	None posted

Products

3 strengths and forms


Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx
Irinotecan Hydrochloride300MG/15ML (20MG/ML) · injectable;injection	Irinotecan Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 28, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Oct 28, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jun 12, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Dec 28, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 208718
Drugs@FDA: Overview at FDA
Company: Adaptis

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