← FDA DRUG APPROVALS

FDA NDA · NDA021437

EPLERENONE

Sponsor: UPJOHN

APPLICATION
NDA021437
TYPE
NDA
ORIGINAL APPROVAL
2002-09-27
LATEST ACTION
2025-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

INSPRADiscontinued
EPLERENONE 100MG · TABLET · ORAL
INSPRA · ReferencePrescription
EPLERENONE 25MG · TABLET · ORAL
INSPRA · ReferencePrescription
EPLERENONE 50MG · TABLET · ORAL

Approval history

2025-06-16Labeling · Supplement 18 · standard — Label ↗AP
2018-05-30Labeling · Supplement 15 · standard — Letter ↗AP
2016-05-04Labeling · Supplement 13 · standard — Label ↗AP
2013-07-26Manufacturing (CMC) · Supplement 12 · standardAP
2013-05-16Labeling · Supplement 11 · standard — Label ↗AP
2013-04-15Manufacturing (CMC) · Supplement 10 · standardAP
2012-06-22Labeling · Supplement 9 · unknown — Letter ↗AP
2008-05-07Labeling · Supplement 6 · standard — Label ↗AP
2008-01-31Efficacy · Supplement 5 · unknown — Label ↗AP
2003-10-07Efficacy · Supplement 2 · priority — Letter ↗AP
2002-09-27Type 1 - New Molecular Entity · Original · unknown — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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