Eprosartan Mesylate

ANDA 202012, held by Pharmobedient. Eprosartan Mesylate.

As of Nov 15, 2026, ANDA 202012 (Eprosartan Mesylate), held by Pharmobedient, was first approved by FDA on Nov 16, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 16, 2011
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
Nov 16, 2011	Original application	Approved	Letter

Products

2 strengths and forms


Eprosartan MesylateEQ 400MG BASE · tablet;oral	Eprosartan Mesylate	Discontinued
Eprosartan MesylateEQ 600MG BASE · tablet;oral	Eprosartan Mesylate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 20, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 20, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 20, 2013	Supplement 1Labeling	Approved	None posted
Nov 16, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 202012
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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