Imatinib Mesylate

ANDA 204644, held by Mylan. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 204644 (Imatinib Mesylate), held by Mylan, was first approved by FDA on Jun 21, 2017, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 21, 2017
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Imatinib mesylate tablets are 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 21, 2017	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 8 submissions, including labeling and manufacturing supplements


Dec 9, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 5, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jun 21, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204644
Drugs@FDA: Overview at FDA
Company: Mylan

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