Viewing data from:

EPLERENONE

ANDA

EPLERENONE | A203896 | INNOGENIX LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

INDUSTRIALE CHIMICA SRLEPLERENONE

DMF 197152006

MSN LABORATORIES PRIVATE LTDEPLERENONE [ROUTE CODE: PL]

DMF 234662010

AURISCO PHARMACEUTICAL CO LTDEPLERENONE

DMF 276722013

INDUSTRIALE CHIMICA SRLEPLERENONE PH. EUR.

DMF 329982018

HETERO LABS LTDEPLERENONE

DMF 338322019

ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTDEPLERENONE API

DMF 370242022

APOTEX PHARMACHEM INCInactiveEPLERENONE MEK HEMISOLVATE (1:0.5)

DMF 197962006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 2, 2017

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 2, 2017

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INNOGENIX acquired ANDA 203896 for eplerenone from AARXION ANDA HOLDING, becoming the new applicant for this generic product.

Old: AARXION ANDA HLDING

New: INNOGENIX

MODIFIEDApplicant Full Name7/1/2026

INNOGENIX LLC replaced AARXION ANDA HOLDING LLC as the applicant for eplerenone ANDA 203896.

Old: AARXION ANDA HOLDING LLC

New: INNOGENIX LLC