Eplerenone

As of Nov 15, 2026, ANDA 78510 (Eplerenone), held by Sandoz, was first approved by FDA on Aug 1, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 1, 2008
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Aug 1, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Eplerenone25MG · tablet;oral	Eplerenone	Rx
Eplerenone50MG · tablet;oral	Eplerenone	Rx

All 9 submissions, including labeling and manufacturing supplements


Aug 31, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 16, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Oct 14, 2014	Supplement 11Manufacturing	Approved	None posted
Feb 20, 2013	Supplement 4Labeling	Approved	None posted
Feb 20, 2013	Supplement 6Labeling · Standard review	Approved	None posted
May 13, 2011	Supplement 2Labeling	Approved	None posted
Aug 1, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78510
Drugs@FDA: Overview at FDA
Company: Sandoz

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