Imatinib Mesylate

ANDA 207586, held by Hikma. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 207586 (Imatinib Mesylate), held by Hikma, was first approved by FDA on Jul 13, 2018, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 13, 2018	Original application	Approved	None posted

Products

2 strengths and forms


Imatinib MesylateEQ 100MG BASE · tablet;oral	Imatinib Mesylate	Discontinued
Imatinib MesylateEQ 400MG BASE · tablet;oral	Imatinib Mesylate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 28, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Mar 28, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Mar 28, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 20, 2018	Supplement 1Manufacturing	Approved	None posted
Nov 20, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Jul 13, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 207586
Drugs@FDA: Overview at FDA
Company: Hikma

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