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FDA NDA · NDA206143

CORLANOR

ivabradine

Sponsor: AMGEN INC

APPLICATION
NDA206143
TYPE
NDA
ORIGINAL APPROVAL
2015-04-15
LATEST ACTION
2021-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CORLANOR · ReferenceDiscontinued
IVABRADINE HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
CORLANOR · ReferenceDiscontinued
IVABRADINE HYDROCHLORIDE EQ 7.5MG BASE · TABLET · ORAL

Approval history

2021-08-04Labeling · Supplement 8 · standard — Label ↗AP
2019-05-13Labeling · Supplement 7 · standard — Label ↗AP
2017-01-10Labeling · Supplement 2 · standard — Label ↗AP
2016-05-05Manufacturing (CMC) · Supplement 1 · priorityAP
2015-04-15Type 1 - New Molecular Entity · Original · priority — Pediatric Written Request ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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