Imatinib Mesylate

ANDA 207495, held by Amneal Pharms. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 207495 (Imatinib Mesylate), held by Amneal Pharms, was first approved by FDA on Feb 8, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 8, 2019
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
Feb 8, 2019	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 4 submissions, including labeling and manufacturing supplements


Sep 25, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Sep 25, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Sep 25, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Feb 8, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 207495
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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