Imatinib Mesylate

ANDA 204285, held by Teva Pharms USA. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 204285 (Imatinib Mesylate), held by Teva Pharms USA, was first approved by FDA on Aug 4, 2016, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 4, 2016
Supplements approved: 9
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 10 submissions below

Date	Submission	Status	Documents
Aug 4, 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 10 submissions, including labeling and manufacturing supplements


Mar 20, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Mar 20, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Mar 20, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jan 9, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Aug 17, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Aug 4, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204285
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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