Imatinib Mesylate

ANDA 206547, held by Dr Reddys. Imatinib Mesylate.

As of Nov 15, 2026, ANDA 206547 (Imatinib Mesylate), held by Dr Reddys, was first approved by FDA on Aug 13, 2018, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 13, 2018
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 13, 2018	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 7 submissions, including labeling and manufacturing supplements


Apr 2, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Aug 16, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Aug 16, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Aug 16, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Aug 16, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Mar 25, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Aug 13, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 206547
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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