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EPLERENONE

ANDA

EPLERENONE | A208283 | BRECKENRIDGE PHARMACEUTICAL INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: INSPRA(TE code: AB)

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: Sep 14, 2018

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 14, 2018