Eplerenone

ANDA 203896, held by Andas 5 Holding. Eplerenone.

As of Nov 15, 2026, ANDA 203896 (Eplerenone), held by Andas 5 Holding, was first approved by FDA on Feb 2, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 2, 2017
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 2, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Eplerenone25MG · tablet;oral	Eplerenone	Discontinued
Eplerenone50MG · tablet;oral	Eplerenone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 25, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Apr 11, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Feb 2, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203896
Drugs@FDA: Overview at FDA
Company: ANDAS 5 Holding

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