Imatinib Mesylate

ANDA 79179, held by Apotex. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 79179 (Imatinib Mesylate), held by Apotex, was first approved by FDA on Aug 5, 2016, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 5, 2016
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Imatinib mesylate is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
Adult patients with myelodys…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 5, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Sep 17, 2026	Supplement 22Labeling · Standard review	Approved	None posted
Sep 17, 2026	Supplement 24Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Aug 17, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Aug 5, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 79179
Drugs@FDA: Overview at FDA
Company: Apotex

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