← FDA Drug Approvals (Drugs@FDA)

EPLERENONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE · Approved 2018-09-14

Drug application

FDA Application #

ANDA208283

Application type

Abbreviated New Drug Application (Generic)

Brand name

EPLERENONE

Generic name

EPLERENONE

Active ingredients

EPLERENONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

BRECKENRIDGE

Manufacturer

Breckenridge Pharmaceutical, Inc.

First approval

2018-09-14

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown